510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K170480Substantially Equivalent

Models 3543A, 4343A, 2929A and A843B

Shanghai PZ Medical Technolgoy Co., Ltd., Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170480 is the FDA 510(k) clearance record for Models 3543A, 4343A, 2929A and A843B, a class II device, cleared for Shanghai PZ Medical Technolgoy Co., Ltd. on under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)). FDA records list one 510(k) clearance for Shanghai PZ Medical Technolgoy Co., Ltd. As of , FDA records show no recalls naming K170480.

Clearance record

Decision date
Received
(141 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
Shanghai PZ Medical Technolgoy Co., Ltd. 5f, Bldg. 13 #2 Suide Rd., Shanghai, 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