510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904144Substantially Equivalent

Pulmovision Chest Radiography X-Ray System

Mallinckrodt Group, Inc., Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904144 is the FDA 510(k) clearance record for PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM, a class II device, cleared for Mallinckrodt Group, Inc. on under FDA product code IZP (Programmer, Changer, Film/Cassette, Radiographic). FDA records list 27 510(k) clearances for Mallinckrodt Group, Inc., from to . As of , FDA records show no recalls naming K904144.

Clearance record

Decision date
Received
(97 days to decision)
Product code
IZP Programmer, Changer, Film/Cassette, Radiographic
Regulation
21 CFR 892.1870
Device class
Class II
Review panel
Radiology
Applicant
Mallinckrodt Group, Inc. 2111 E. Galbraith Rd., Cincinnati OH
Third party review
No

Clearances, product code IZP

Trailing 12 months

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

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