510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K210916Substantially Equivalent

PVmed Contouring Software

Perception Vision Medical Technologies Ltd.Co., Guangzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210916 is the FDA 510(k) clearance record for PVmed Contouring Software, a class II device, cleared for Perception Vision Medical Technologies Ltd.Co. on under FDA product code LLZ (System, Image Processing, Radiological). FDA records list one 510(k) clearance for Perception Vision Medical Technologies Ltd.Co. As of , FDA records show no recalls naming K210916.

Clearance record

Decision date
Received
(249 days to decision)
Product code
LLZ System, Image Processing, Radiological
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Perception Vision Medical Technologies Ltd.Co. Rm. 306, First Phase Office Bldg., # 12, Guangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LLZ

Trailing 12 months
48 clearances under product code LLZ in the twelve months to October 2026, July 2026 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code LLZ, trailing twelve months
MonthClearances
November 20254
December 20251
January 20263
February 20264
March 20266
April 20262
May 20265
June 20265
July 20268
August 20263
September 20267
October 20260