Medical Device Manufacturer · US , Campbell , CA

Careray Digital Medical System Co., Ltd. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2015

Recent clearances: X-ray Flat Panel Detectors/CareView 3600RF, X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe), CareView 1800Le

10
Total
10
Cleared
0
Denied

FDA 510(k) Regulatory Record - Careray Digital Medical System Co., Ltd. Radiology ✕

10 devices
1-10 of 10
Cleared Feb 19, 2021
X-ray Flat Panel Detectors/CareView 3600RF
K202995 · MQB
Radiology · 141d
Cleared Aug 07, 2020
X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
K201932 · MQB
Radiology · 25d
Cleared Dec 13, 2019
CareView 1800Le
K193173 · MQB
Radiology · 25d
Cleared Sep 26, 2017
CareView 1800Cw X-ray Flat Panel Detectors
K172581 · MQB
Radiology · 29d
Cleared Dec 01, 2016
CareView 750Cw/750C X-ray Flat Panel Detectors
K163019 · MQB
Radiology · 31d
Cleared Sep 01, 2016
CareView 1500P X-ray Flat Panel Detectors
K162178 · MQB
Radiology · 28d
Cleared Dec 24, 2015
CareView 1800L
K153492 · MQB
Radiology · 20d
Cleared Nov 10, 2015
CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
K153058 · MQB
Radiology · 20d
Cleared Sep 08, 2015
CAREVIEW 1800R
K141488 · MQB
Radiology · 460d
Cleared Aug 04, 2015
CareView 1500Cw X-ray Flat Panel Detectors
K150929 · MQB
Radiology · 120d
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