510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K844298Substantially Equivalent

Adac Model Dps-3300M Digital Processing System

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

K844298 is the FDA 510(k) clearance record for ADAC MODEL DPS-3300M DIGITAL PROCESSING SYSTEM, a class II device, cleared for Adac Laboratories on under FDA product code LLZ (System, Image Processing, Radiological). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K844298.

Clearance record

Decision date
Received
(122 days to decision)
Product code
LLZ System, Image Processing, Radiological
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Adac Laboratories 255 San Geronimo Way, Sunnvale CA
Third party review
No

Clearances, product code LLZ

Trailing 12 months
48 clearances under product code LLZ in the twelve months to October 2026, July 2026 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code LLZ, trailing twelve months
MonthClearances
November 20254
December 20251
January 20263
February 20264
March 20266
April 20262
May 20265
June 20265
July 20268
August 20263
September 20267
October 20260