510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K903576Substantially Equivalent

Puck 90M

Elema-Schonander, Inc., Schaumburg IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903576 is the FDA 510(k) clearance record for PUCK 90M, a class II device, cleared for Elema-Schonander, Inc. on under FDA product code KPX (Changer, Radiographic Film/Cassette). FDA records list 11 510(k) clearances for Elema-Schonander, Inc., from to . As of , FDA records show no recalls naming K903576.

Clearance record

Decision date
Received
(27 days to decision)
Product code
KPX Changer, Radiographic Film/Cassette
Regulation
21 CFR 892.1860
Device class
Class II
Review panel
Radiology
Applicant
Elema-Schonander, Inc. 2360 N. Palmer Dr., Schaumburg IL
Third party review
No

Clearances, product code KPX

Trailing 12 months

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

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