IRAY IMAGING LLC

FDA Device Registration & Listing · Solon, OH, US · Registration 3030898585

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
3030898585
FEI Number
3030898585
Entity Name
IRAY IMAGING LLC
City/State/Country
Solon, OH, US
Establishment Address
29001 Solon Rd Unit A Solon Oh - 44139-3469, Solon, OH 44139, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
IRAY Imaging LLC (Owner Number: 10091237)
Owner / Operator Contact Address
29001 Solon Rd Unit A, Solon, OH - 44139-3469, Solon, OH 44139, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Flat Panel Detector

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2024-11-13
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2025-04-21
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2025-08-08
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2025-04-09

Official Correspondent

Hao Chen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IRAY Imaging LLC
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
K070563 Vidar Systems Corp. VIDAR VISION 2000 2007-03-16
K190691 Pixxgen Corporation Pixx2430 Digital Diagnostic X-Ray Receptor Panel 2019-04-04
K150150 Rayence Co., Ltd. 1717SGN / 1717SCN Digital Flat Panel X-ray Detector 2015-03-27
K140771 Philips Medical Systems Dmc GmbH PHILIPS ELEVA WORKSPOT 2014-04-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2009 Toshiba American Medical Systems Inc 2
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007 AGFA Corp. 2
CR DX-S, Image Intensified Fluoroscopic X-ray system.

Similar Registrations

Registration Number Establishment Name Location
3016256852 KA IMAGING INC. Waterloo Ontario, CA
3011825597 FAIR MEDICAL CO.,LTD Kashiwa Chiba, JP
3038614464 Canon.Inc OHTA-KU Tokyo, JP
9614698 CANON INC. OTAWARA-SHI Tochigi, JP
3003775006 FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office HANAMAKI-SHI Iwate, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030898585. Last updated year: 2026. Please use registration number 3030898585 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.