510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K850823Substantially Equivalent

Srx 200 Diagnostic X-Ray, High Voltage Generator

Philips North America LLC, Highland Heights OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850823 is the FDA 510(k) clearance record for SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR, a class I device, cleared for Philips Medical Systems (Cleveland), Inc. on under FDA product code IZO (Generator, High-Voltage, X-Ray, Diagnostic). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K850823.

Clearance record

Decision date
Received
(41 days to decision)
Product code
IZO Generator, High-Voltage, X-Ray, Diagnostic
Regulation
21 CFR 892.1700
Device class
Class I
Review panel
Radiology
Applicant
Philips Medical Systems (Cleveland), Inc. 5500 Avion Park Dr., Highland Heights OH
Third party review
No

Clearances, product code IZO

Trailing 12 months

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

FDA records show no clearances under product code IZO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IZO, 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