Skip to content

X-ray Flat Panel Detectors/CareView 3600RF

by Careray Digital Medical System Co., Ltd.

510(k) K202995

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK202995 Date19 Feb 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MQB
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

X-ray Flat Panel Detectors/CareView 3600RF is a solid state X-ray imager (flat panel/digital imager) used for digital imaging in general radiographic diagnosis of human anatomy. It is designed to replace radiographic film/screen systems in all general-purpose diagnostic procedures.

The device is supplied by Careray Digital Medical System Co., Ltd. and has received FDA 510(k) clearance under K202995, with a decision date of 2021-02-19. It is classified as a Class II device under regulation number 892.1680 and product code MQB, and is intended for use in radiology settings.

Other devices from Careray Digital Medical System Co., Ltd.

See all devices from Careray Digital Medical System Co., Ltd. →

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CareView 3600RF used for?

    The CareView 3600RF is a solid-state X-ray imager (flat panel/digital imager) used for digital imaging in general radiographic diagnosis of human anatomy, designed to replace radiographic film/screen systems in all general-purpose diagnostic procedures.

  • Who manufactures the CareView 3600RF and where is it supplied from?

    The CareView 3600RF is manufactured and supplied by Careray Digital Medical System Co., Ltd., located in Suzhou Industrial Park, Suzhou, China.

  • What regulatory clearance does the CareView 3600RF have?

    The CareView 3600RF has received FDA 510(k) clearance under K202995, with a decision date of February 19, 2021, and is classified as a Class II device under regulation number 892.1680 and product code MQB.