510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K900689Substantially Equivalent

Modified Adac Nuclear Medicine Gamma Camera

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

K900689 is the FDA 510(k) clearance record for MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA, a class I device, cleared for Adac Laboratories 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 K900689.

Clearance record

Decision date
Received
(65 days to decision)
Product code
IYX Camera, Scintillation (Gamma)
Regulation
21 CFR 892.1100
Device class
Class I
Review panel
Radiology
Applicant
Adac Laboratories 540 Alder Dr., Milpitas CA
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