RAY AMERICA INC

FDA Device Registration & Listing · Fort Lee, NJ, US · Registration 3011471624

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011471624
FEI Number
3011471624
Entity Name
RAY AMERICA INC
City/State/Country
Fort Lee, NJ, US
Establishment Address
400 Kelby Street, Ste. 1500, Fort Lee, NJ 07024, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
RAY AMERICA INC (Owner Number: 10048938)
Owner / Operator Contact Address
400 Kelby Street, Ste. 1500, Fort Lee, NJ 07024, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K251109
PMA Number
N/A

All Registered Proprietary Names

RIOSCAN RAYiOS2 RAYiOS RCT700 VISION 16 RAYSCAN ALPHA PLUS RAYDENT C&B RAYSCAN a+ RAYSCAN ALPHA PLUS RCT700 VISION 16 RCT800 RAYSCAN STUDIO RAYQUANTUM RCT600 Computed Tomography X-ray System RIT-MU RIT-LL RIT-SU RIT-LU RIT-ML RIT-PB RIT-SL RIT-PA RAYDENT DM Cocoon Portable Handheld X-Ray System RAYSCAN ?-Expert RAYSCAN A+ RCT700 RAYSCAN A+ Vision 16 RCT800 RAYSCAN STUDIO RAYSCAN S RAYSCAN S Vision 20 RAYSCAN STUDIO VISION 20 VISION 18 RAYPreMiere RAYSCAN S RCT800 RAYSCAN ?-Expert 3D SMARTDent

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2016-09-21
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2022-08-17
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2025-12-15
ELJ Teeth, Artificial, Posterior With Metal Insert Dental Class 1 872.3900 2017-07-12
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2024-12-12
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2019-01-03
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2025-05-01
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2019-01-03
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2017-07-12
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2024-07-15
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2015-05-07
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2019-01-03
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2019-12-23
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2024-02-13
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2015-05-07
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-12-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RAY AMERICA INC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221008 Shanghai Handy Medical Equipment Co., Ltd. HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) 2022-06-22
K160788 Ray Co., Ltd. RIOScan (RPS500) 2016-04-15
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number Establishment Name Location
3042046320 QPIX SOLUTIONS, INC. Morrisville, NC, US
3020117925 ATHLOS OY Espoo Uusimaa, FI
2032641 CYBER MEDICAL IMAGING, INC. Los Angeles, CA, US
3004706313 VATECH CO., LTD. Hwaseong-si Gyeonggi, KR
3010281549 J. MORITA MFG. CORP., TOTTORI FACTORY Kurayoshi Tottori, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011471624. Last updated year: 2026. Please use registration number 3011471624 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.