510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K993923Substantially Equivalent

Adac Pinnacle3tm Radiation Therapy Planning System

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

K993923 is the FDA 510(k) clearance record for ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM, a class II device, cleared for Adac Laboratories on under FDA product code MUJ (System, Planning, Radiation Therapy Treatment). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K993923.

Clearance record

Decision date
Received
(141 days to decision)
Product code
MUJ System, Planning, Radiation Therapy Treatment
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Adac Laboratories 540 Alder Dr., Milpitas CA
510(k) summary
Summary
Third party review
No

Clearances, product code MUJ

Trailing 12 months
12 clearances under product code MUJ in the twelve months to November 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MUJ, trailing twelve months
MonthClearances
December 20253
January 20260
February 20262
March 20261
April 20260
May 20263
June 20261
July 20261
August 20260
September 20260
October 20261
November 20260