X-ray Flat Panel Detectors/CareView 3600RF— 510(k) K202995

Name: FDA 510(k) clearance K202995
Creator: U.S. Food and Drug Administration
Published: 2021-02-19

Substantially Equivalent

Careray Digital Medical System Co., Ltd.

FDA 510(k) clearance K202995 for X-ray Flat Panel Detectors/CareView 3600RF, Substantially Equivalent on 2021-02-19. Applicant: Careray Digital Medical System Co., Ltd.. Device class: 2.

Clearance details

Applicant: Careray Digital Medical System Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2020-10-01
Decision date: 2021-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQB

view all

K253800 — 0909FCE, 0909FCE-HS2026-07-31
K260820 — VIVIX-S 4386W (FXRD-4386WA)2026-06-18
K252996 — Universal 1417PI2026-06-12
K252911 — Lux HD 2530 detector (Lux HD 2530)2025-10-09
K250211 — Yushan X-Ray Flat Panel Detector2025-07-22

More clearances from Careray Digital Medical System Co., Ltd.

view all

K201932 — X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)2020-08-07
K193173 — CareView 1800Le2019-12-13
K172581 — CareView 1800Cw X-ray Flat Panel Detectors2017-09-26
K163019 — CareView 750Cw/750C X-ray Flat Panel Detectors2016-12-01
K162178 — CareView 1500P X-ray Flat Panel Detectors2016-09-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.