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
K885327Substantially Equivalent

Philips Digital Cardiac Imaging (Dci) System

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

K885327 is the FDA 510(k) clearance record for PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM, a class I device, cleared for Philips Medical Systems North America, Inc. on under FDA product code LMB (Device, Digital Image Storage, Radiological). FDA's definition for product code LMB reads: "Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images". FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K885327.

Clearance record

Decision date
Received
(134 days to decision)
Product code
LMB Device, Digital Image Storage, Radiological
Regulation
21 CFR 892.2010
Device class
Class I
Review panel
Radiology
Applicant
Philips Medical Systems North America, Inc. 710 Bridgeport Ave., Shelton CT
Third party review
No

Clearances, product code LMB

Trailing 12 months

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

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