510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091628Substantially Equivalent

Optimax, Compact 2, Optimax 2010, Ecomax

Protec GmbH & Co. KG, Oberstenfeld, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091628 is the FDA 510(k) clearance record for OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX, a class II device, cleared for Protec GmbH & Co. KG on under FDA product code IXW (Processor, Radiographic-Film, Automatic). FDA records list 2 510(k) clearances for Protec GmbH & Co. KG, from to . As of , FDA records show no recalls naming K091628.

Clearance record

Decision date
Received
(78 days to decision)
Product code
IXW Processor, Radiographic-Film, Automatic
Regulation
21 CFR 892.1900
Device class
Class II
Review panel
Radiology
Applicant
Protec GmbH & Co. KG Lichtenberger St. 35, Oberstenfeld, DE
510(k) summary
Summary PDF
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