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Data / Medical devices / United States / Ray America Inc

Ray America Inc: FDA-registered device maker in Fort Lee, NJ, United States, 15 510(k) clearances

Ray America Inc is registered with the FDA (registration 3011471624) in Fort Lee, NJ, United States. It lists 11 device types. The FDA files 15 510(k) clearances under its listings, the newest dated November 25, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Ray America Inc
FDA registration number
3011471624
Address
400 Kelby Street Ste. 1500, Fort Lee, NJ, United States, 07024
Owner or operator
RAY AMERICA INC (10048938)
Roles
Complaint file establishment
First device listed
March 23, 2015
Registered through
2027
Brand names listed
Cocoon Portable Handheld X-Ray System, RAYDENT C&B, RAYDENT DM, RAYDENT SG, RAYDENT SW, RAYPreMiere, RAYQUANTUM, RAYSCAN ?-Expert and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Complaint file establishmentaccessdata.fda.gov
Material, Impression Tray, ResinEBH1Complaint file establishmentaccessdata.fda.gov
Orthodontic SoftwarePNN2Complaint file establishmentaccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Complaint file establishmentaccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Complaint file establishmentaccessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsNOF2Complaint file establishmentaccessdata.fda.gov
System, X-Ray, Extraoral Source, DigitalMUH2Complaint file establishmentaccessdata.fda.gov
Teeth, Artificial, Posterior With Metal InsertELJ1Complaint file establishmentaccessdata.fda.gov
Tray, Impression, PreformedEHY1Complaint file establishmentaccessdata.fda.gov
Unit, X-Ray, IntraoralEAP2Complaint file establishmentaccessdata.fda.gov
X-Ray, Tomography, Computed, DentalOAS2Complaint file establishmentaccessdata.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
November 25, 2025K251798RCT700OASSubstantially EquivalentRay Co., Ltd.accessdata.fda.gov
May 21, 2025K251109SMARTDentLLZSubstantially EquivalentRay Co., Ltd.accessdata.fda.gov
March 12, 2025K243903RCT600OASSubstantially EquivalentRay Co., Ltd.accessdata.fda.gov
May 16, 2024K233625RAYDENT SWPNNSubstantially EquivalentRay Co., Ltd.accessdata.fda.gov
April 11, 2023K230753RCT800OASSubstantially EquivalentRay Co., Ltd.accessdata.fda.gov
November 29, 2021K213226RCT700OASSubstantially EquivalentRay Co., Ltd.accessdata.fda.gov
October 22, 2019K192737RCT800OASSubstantially EquivalentRay Co., Ltd.accessdata.fda.gov
December 14, 2018K182805RCT800OASSubstantially EquivalentRay Co., Ltd.accessdata.fda.gov
October 16, 2018K182614RCT700OASSubstantially EquivalentRay Co., Ltd.accessdata.fda.gov
October 26, 2017K173046Cocoon Portable Handheld X-Ray SystemMUHSubstantially EquivalentDexcowin Co., Ltd.accessdata.fda.gov
April 15, 2016K160788RIOScan (RPS500)MUHSubstantially EquivalentRay Co., Ltd.accessdata.fda.gov
April 22, 2015K142058RAYSCAN A-EXPERTMUHSubstantially EquivalentRay Co., Ltd.accessdata.fda.gov
April 17, 2015K142247RAYSCAN A-EXPERT 3DOASSubstantially EquivalentRay Co., Ltd.accessdata.fda.gov
January 23, 2015K143000RIS500MQBSubstantially EquivalentRay Co., Ltd.accessdata.fda.gov
April 19, 1995K950532TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHYEAPSubstantially EquivalentTrophy Radiologieaccessdata.fda.gov

Compare with other makers

Updated November 25, 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.