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Data / Medical devices / United States / Metropolis International, LLC

Metropolis International, LLC: FDA-registered device maker in Long Island City, NY, United States, 46 510(k) clearances and 2 PMA approvals

Metropolis International, LLC is registered with the FDA (registration 3005877899) in Long Island City, NY, United States. It lists 52 device types. The FDA files 46 510(k) clearances and 2 PMA approvals under its listings, the newest dated May 13, 2022. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Metropolis International, LLC
FDA registration number
3005877899
Address
38-13 10th Street, Long Island City, NY, United States, 11101
Owner or operator
Metropolis International, LLC (10043887)
Roles
Remanufacturer, Repackager or relabeler
First device listed
July 15, 2021
Registered through
2026
Brand names listed
Esaote G-Scan Brio, GE Performix Tube, Hologic, Inc., Metropolis International, Siemens Healthineers

Devices it lists

DeviceProduct codeClassRoleSource
Alarm, Blood-PressureDSJ2Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)NHO2Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)CBQ2Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)CBS2Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)NHQ2Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)CBR2Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-PhaseCCL2Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)NHP2Repackager or relabeleraccessdata.fda.gov
Assembly, Tube Housing, X-Ray, DiagnosticITY1Repackager or relabeleraccessdata.fda.gov
Biopsy Needle Guide KitOIJ2Repackager or relabeleraccessdata.fda.gov
Burst Suppression Detection Software For ElectroencephalographORT2Repackager or relabeleraccessdata.fda.gov
Catheter, Ultrasound, IntravascularOBJ2Repackager or relabeleraccessdata.fda.gov
Coil, Magnetic Resonance, SpecialtyMOS2Repackager or relabeleraccessdata.fda.gov
Computer, Blood-PressureDSK2Repackager or relabeleraccessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-FunctionDXG2Repackager or relabeleraccessdata.fda.gov
Computer, Diagnostic, ProgrammableDQK2Repackager or relabeleraccessdata.fda.gov
Computer, Oxygen-UptakeBZL2Repackager or relabeleraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Repackager or relabeleraccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Repackager or relabeleraccessdata.fda.gov
Digital Breast TomosynthesisOTE3Repackager or relabeleraccessdata.fda.gov
ElectrocardiographDPS2Repackager or relabeleraccessdata.fda.gov
Full Field Digital, System, X-Ray, MammographicMUE2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Full-Montage Standard ElectroencephalographGWQ2Repackager or relabeleraccessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, MobileOXO2Repackager or relabeleraccessdata.fda.gov
Index-Generating Electroencephalograph SoftwareOLW2Repackager or relabeleraccessdata.fda.gov
Interventional Fluoroscopic X-Ray SystemOWB2Repackager or relabeleraccessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)CAP2Repackager or relabeleraccessdata.fda.gov
Monitor, Breathing FrequencyBZQ2Repackager or relabeleraccessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2Repackager or relabeleraccessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2Repackager or relabeleraccessdata.fda.gov
Monitor, St Segment With AlarmMLD2Repackager or relabeleraccessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph SoftwareOLT2Repackager or relabeleraccessdata.fda.gov
OximeterDQA2Repackager or relabeleraccessdata.fda.gov
Oximeter, EarDPZ2Repackager or relabeleraccessdata.fda.gov
Probe, ThermodilutionKRB2Repackager or relabeleraccessdata.fda.gov
Reduced- Montage Standard ElectroencephalographOMC2Repackager or relabeleraccessdata.fda.gov
Spirometer, Monitoring (W/Wo Alarm)BZK2Repackager or relabeleraccessdata.fda.gov
Stimulator, Auditory, Evoked ResponseGWJ2Repackager or relabeleraccessdata.fda.gov
Stimulator, Nerve, Peripheral, ElectricKOI2Repackager or relabeleraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Repackager or relabeleraccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Repackager or relabeleraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Repackager or relabeleraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Repackager or relabeleraccessdata.fda.gov
System, Nuclear Magnetic Resonance ImagingLNH2Repackager or relabeleraccessdata.fda.gov
System, Nuclear Magnetic Resonance SpectroscopicLNI2Repackager or relabeleraccessdata.fda.gov
System, Tomography, Computed, EmissionKPS2Repackager or relabeleraccessdata.fda.gov
System, X-Ray, AngiographicIZI2Repackager or relabeleraccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Repackager or relabeleraccessdata.fda.gov
System, X-Ray, MobileIZL2Repackager or relabeleraccessdata.fda.gov
System, X-Ray, Tomography, ComputedJAK2Repackager or relabeleraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 13, 2022K220589MAGNETOM Skyra FitLNHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
June 10, 2021K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
January 8, 2021K203114LOGIQ P10, LOGIQ P9, LOGIQ P8IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
October 15, 2020K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound SystemIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
September 8, 2020K202014Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fitLNHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
January 21, 2020K191149CARESCAPE B650MHXSubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
August 20, 2019K182086ARCO FPOWBSubstantially EquivalentA.T.S. Applicazione Tecnologie Speciali S.R.L.accessdata.fda.gov
July 29, 2019K191136Access CTJAKSubstantially EquivalentPhilips Healthcare (Suzhou) Co., Ltd.accessdata.fda.gov
April 15, 2019K183548SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16JAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 27, 2018K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound SystemIYNSubstantially EquivalentPhilips Ultrasound, Inc.accessdata.fda.gov
February 28, 2018K173739ALOKA ARIETTA 850IYNSubstantially EquivalentHitachi Healthcare Americas Corporationaccessdata.fda.gov
November 17, 2017K173023Symbia T16, Symbia Intevo 16 and Symbia Intevo BoldKPSSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
October 25, 2016K161973G-scan Brio, S-scanLNHSubstantially EquivalentEsaote, S.p.A.accessdata.fda.gov
August 8, 2016K160743Philips Ingenuity CTJAKSubstantially EquivalentPhilips Medical Systems (Cleveland), Inc.accessdata.fda.gov
April 15, 2016K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitLNHSubstantially EquivalentSiemens Medi Cal Solutions, Inc.accessdata.fda.gov
October 10, 2014K142037QUANTRALLZSubstantially EquivalentHologic, Inc.accessdata.fda.gov
September 25, 2014K142383Optima XR200amx, Optima XR220amxIZLSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
July 10, 2014K133819VERADIUSOWBSubstantially EquivalentPhilips Medical Systems Nederland B.V.accessdata.fda.gov
December 4, 2013K132533CARESCAPE MONITOR B450MHXSubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
September 24, 2013K131773BRILLIANCE ICTJAKSubstantially EquivalentPhilips Healthcare (Cleveland)accessdata.fda.gov
August 28, 2013K131223CARESCAPE MONITOR B650MHXSubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
June 11, 2013K123520MAMMOMAT INSPIRATION PRIMEMUESubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
May 21, 2013K130842ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIESIZISubstantially EquivalentPhilips Medical Systems Nederland B.V.accessdata.fda.gov
May 17, 2013K123603OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIMEOXOSubstantially EquivalentGe Healthcare Surgery GE Oec Medical Systems, Inc.accessdata.fda.gov
February 22, 2013K122286MAMMOMAL INSPIRATIONMUESubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
January 29, 2013K123873CONTRAST ENHANCED DIGITAL MAMMOGRAPHYMUESubstantially EquivalentHologic, Inc.accessdata.fda.gov
December 18, 2012K123564LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
May 23, 2012K113287SOMATOM PERSPECTIVEJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
December 17, 2011K113448BIOGRAPH MCT FAMILYKPSSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 20, 2011K110227OPTIMA CT660JAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
June 16, 2011K103476BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMXIZLSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
March 22, 2011K110151ACHIEVA R4 1.5T AND ACHIEVA R4 3.0TLNHSubstantially EquivalentPhilips Health Careaccessdata.fda.gov
August 28, 2009K092027CARESCAPE MONITOR B850MHXSubstantially EquivalentGe Medical Systems Information Technologiesaccessdata.fda.gov
June 30, 2009K090268SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTIONIZLSubstantially EquivalentShimadzu Corp.accessdata.fda.gov
June 18, 2009K090745ARTIS ZEE / ZEEGOS WITH SW VC14IZISubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
May 1, 2009K082781OEC 9900 ELITEOWBSubstantially EquivalentGe Healthcare Surgeryaccessdata.fda.gov
June 11, 2008K081091PRECISION 500D R&F X-RAY SYSTEMJAASubstantially EquivalentGE Healthcareaccessdata.fda.gov
October 10, 2007K072237MAGNETOM VERIOLNHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
June 5, 2006K060937BRILLIANCE VOLUMEJAKSubstantially EquivalentPhilips Medical Systems (Cleveland), Inc.accessdata.fda.gov
June 20, 2005K051367PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000MHXSubstantially EquivalentGe Medical Systems Information Technologiesaccessdata.fda.gov
March 1, 2005K050297SOMATOM EMOTION 16JAKSubstantially EquivalentSiemens Medical Solution, Inc. USAaccessdata.fda.gov
December 23, 2004K043276DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULEMHXSubstantially EquivalentDatex-Ohmedaaccessdata.fda.gov
December 9, 2003K033737ALLURA XPER FD20OWBSubstantially EquivalentPhilips Medical Systems North America, Inc.accessdata.fda.gov
June 17, 2002K021016AMX-4 PLUS MOBILE X-RAY SYSTEMIZLSubstantially EquivalentGE Medical Systemsaccessdata.fda.gov
December 28, 2001K013586MAGNETOM TRIO SYSTEMLNHSubstantially EquivalentSiemens Medical Systems, Inc.accessdata.fda.gov
January 24, 1997K964746HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTIONJAKSubstantially EquivalentGE Medical Systemsaccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
February 11, 2011P080003SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMOTE10November 24, 2025accessdata.fda.gov
March 15, 2002P010025LORAD DIGITAL BREAST IMAGERMUE17November 16, 2010accessdata.fda.gov

Compare with other makers

Updated November 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.