510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981280Substantially Equivalent

Cp 1000, Curix Ht 330, Classic E.o.s., Curix Ht 530, Mamoray Ht 300, Mamoray Cmpact Plus, Curix Compact Plus, Curix Coms

Bayer Corp., Agfa Div., Ridgefield Park NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981280 is the FDA 510(k) clearance record for CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS, a class II device, cleared for Bayer Corp., Agfa Div. on under FDA product code IXW (Processor, Radiographic-Film, Automatic). FDA records list 3 510(k) clearances for Bayer Corp., Agfa Div., from to . As of , FDA records show no recalls naming K981280.

Clearance record

Decision date
Received
(22 days to decision)
Product code
IXW Processor, Radiographic-Film, Automatic
Regulation
21 CFR 892.1900
Device class
Class II
Review panel
Radiology
Applicant
Bayer Corp., Agfa Div. 100 Challenger Rd., Ridgefield Park NJ
510(k) summary
Summary
Third party review
No

Clearances, product code IXW

Trailing 12 months

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

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