510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232058Substantially Equivalent

YosemiteView 4343W/YosemiteView 3643W

Careray Digital Medical Technology Co., Ltd., Suzhou, CN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232058 is the FDA 510(k) clearance record for YosemiteView 4343W/YosemiteView 3643W, a class II device, cleared for Careray Digital Medical Technology Co., Ltd. on under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)). FDA records list 3 510(k) clearances for Careray Digital Medical Technology Co., Ltd., from to . As of , FDA records show no recalls naming K232058.

Clearance record

Decision date
Received
(23 days to decision)
Product code
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Careray Digital Medical Technology Co., Ltd. A2-201/B3-501, Biobay 218 Xinghu St.,, Suzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQB

Trailing 12 months
3 clearances under product code MQB in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MQB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20261
August 20260
September 20260
October 20260