510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K904050Substantially Equivalent

Model Dh-1000 Single Detec./dual Detec Nucl Camera

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

K904050 is the FDA 510(k) clearance record for MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA, a class I device, cleared for Philips Medical Systems (Cleveland), Inc. on under FDA product code IYX (Camera, Scintillation (Gamma)). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K904050.

Clearance record

Decision date
Received
(92 days to decision)
Product code
IYX Camera, Scintillation (Gamma)
Regulation
21 CFR 892.1100
Device class
Class I
Review panel
Radiology
Applicant
Philips Medical Systems (Cleveland), Inc. 23060 Miles Rd., Cleveland OH
Third party review
No

Clearances, product code IYX

Trailing 12 months

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

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