Data / Medical devices / United States / Medical Imaging Sale And Service Inc
Medical Imaging Sale And Service Inc: FDA-registered device maker in Farmingdale, NJ, United States, 25 510(k) clearances
Medical Imaging Sale And Service Inc is registered with the FDA (registration 3021059265) in Farmingdale, NJ, United States. It lists 12 device types. The FDA files 25 510(k) clearances under its listings, the newest dated July 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021059265
- Address
- 165 Central Avenue, Farmingdale, NJ, United States, 07727
- Owner or operator
- medical imaging sale and service Inc (10083567)
- Roles
- Repackager or relabeler
- First device listed
- May 22, 2023
- Registered through
- 2026
- Brand names listed
- CT660 Cj2.5 Upgrade, DISCOVERY CT750 HD, GE Healthcare, GE Lightspeed VCT 64 CT Scanner, GE Medical Systems, GE Medical Systems LLC, Hologic, Inc. Digital Mammogram, OPTIMA CT520 and more
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 26, 2024 | K241898 | Symbia SPECT and SPECT/CT Systems | KPS | Substantially Equivalent | Siemens Healthineers | accessdata.fda.gov |
| March 26, 2024 | K233650 | SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 23, 2023 | K231560 | MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 16, 2021 | K212604 | Symbia VA10A Family | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 15, 2019 | K190138 | MAGNETOM Aera | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 6, 2018 | K181613 | MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 15, 2018 | K181407 | Artis zee/zeego & Artis Q/Q.zen | OWB | Substantially Equivalent | Siemens Medical Solution USA, Inc. | accessdata.fda.gov |
| December 11, 2017 | K173612 | Optima XR646 HD | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| April 7, 2017 | K162838 | Philips iCT CT System | JAK | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. | accessdata.fda.gov |
| November 24, 2015 | K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 24, 2014 | K133278 | DISCOVERY IGS 740 | OWB | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| March 21, 2014 | K133657 | DISCOVERY PET/CT 710 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 30, 2013 | K131576 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| May 17, 2013 | K130885 | MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 22, 2013 | K122286 | MAMMOMAL INSPIRATION | MUE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 8, 2013 | K123596 | OPTIMA CT520 | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| January 29, 2013 | K123873 | CONTRAST ENHANCED DIGITAL MAMMOGRAPHY | MUE | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| August 16, 2012 | K122234 | OEC 9900 ELITE | OWB | Substantially Equivalent | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | accessdata.fda.gov |
| June 12, 2012 | K120833 | DISCOVERY CT750 HD | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 26, 2012 | K110066 | AQUILION PRIME | JAK | Substantially Equivalent | Toshiba America Medical Systems, In.C | accessdata.fda.gov |
| October 1, 2010 | K101347 | MAGNETOM AERA; MAGNETOM SKYRA | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 8, 2008 | K082761 | GE LIGHTSPEED 7.2 CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 10, 2007 | K072237 | MAGNETOM VERIO | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 21, 2005 | K052293 | GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 17, 2005 | K050559 | GE DISCOVERY VCT SYSTEM | KPS | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
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Updated July 26, 2024. 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.