Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011158427

FEI Number

3011158427

Entity Name

CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

SuZhou Jiangsu, CN

Establishment Address

A2-201/B3-501, Biobay, 218 Xinghu Street,No. 15, Songbei Road, Suzhou Industrial Park, SuZhou Jiangsu 215123, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CareRay Digital Medical Technology Co., Ltd. (Owner Number: 10050244)

Owner / Operator Contact Address

No. 15, Songbei Road, Suzhou Industrial Park, SuZhou, CN-JS 215024, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172581

PMA Number

N/A

All Registered Proprietary Names

CareView 1800L X-ray Flat Panel Detectors CareView 1500P X-ray Flat Panel Detectors CareView 1500L X-ray Flat Panel Detectors CareView 1500C X-ray Flat Panel Detectors CareView 1800Le X-Ray Flat Panel Detectors CareView 1800R X-ray Flat Panel Detectors CareView 1800RF X-ray Flat Panel Detector EverestView 4343X X-ray Flat Panel Detector CareView 1800Cwe X-ray Flat Panel Detectors CareView 1500Cwe X-ray Flat Panel Detectors CareView 1800Cw X-ray Flat Panel Detectors

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	2015-12-25
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2016-09-05
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2015-11-11
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-12-13
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2015-10-25
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2022-08-22
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-08-22
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2023-01-03
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2023-01-03
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2020-08-10
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2017-10-14

Official Correspondent

Jianqiang Liu

US Agent Details

Mei Shen Business: Compass InnovationsInc. Email: mshen@compassinnovationsinc.com Phone: (408) 4183985

Related Public Records

Same Entity

CareRay Digital Medical Technology Co., Ltd.

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
K863853	Superior Medical Products	EAZY COVERS	1987-03-06

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.
Z-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.

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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 3011158427. Last updated year: 2026. Please use registration number 3011158427 when referencing this establishment in official correspondence.