510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920793Substantially Equivalent

Philips Dsi System Release 3.2

Philips North America LLC, 5680 Da Best, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920793 is the FDA 510(k) clearance record for PHILIPS DSI SYSTEM RELEASE 3.2, a class II device, cleared for Philips Medical Systems, Inc. on under FDA product code IZJ (Camera, X-Ray, Fluorographic, Cine Or Spot). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show 2 recalls naming K920793.

Clearance record

Decision date
Received
(147 days to decision)
Product code
IZJ Camera, X-Ray, Fluorographic, Cine Or Spot
Regulation
21 CFR 892.1620
Device class
Class II
Review panel
Radiology
Applicant
Philips Medical Systems, Inc. Veenpluis 4-6, 5680 Da Best, NL
510(k) summary
Summary
Third party review
No

Clearances, product code IZJ

Trailing 12 months

FDA records hold no clearances under product code IZJ in the trailing twelve months.

FDA records show no clearances under product code IZJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IZJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260