Cleared Traditional

K992818 - OPTIMAX/ COMPACT 2

K992818 is an FDA 510(k) clearance for OPTIMAX/ COMPACT 2, manufactured by Protec GmbH & Co. KG. The device is a Class 2 Radiology device with product code IXW cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K992818 · Protec GmbH & Co. KG · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
12d
Days
Class 2
Risk

K992818 is an FDA 510(k) clearance for the OPTIMAX/ COMPACT 2. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Protec GmbH & Co. KG (Oberstenfeld, DE). The FDA issued a Cleared decision on September 1, 1999 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1900 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Protec GmbH & Co. KG devices

FDA 510(k) Submission Details - K992818

510(k) Number K992818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1999
Decision Date September 01, 1999
Days to Decision 12 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IXW Device Classification - Class 2, Special Controls

Product Code IXW Processor, Radiographic-film, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IXW Processor, Radiographic-film, Automatic

All 45
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K992818.
FREEDOM AUTOMATIC FILM PROCESSOR
K002640 · J. Morita USA, Inc. · Nov 2000
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS
K981280 · Bayer Corp., Agfa Div. · Apr 1998
MAMMOLOADER BY C.M.A. SRL
K973125 · C.M.A. · Oct 1997
KODAK MINILOADER(2000)
K970059 · Eastman Kodak Company · Jan 1997
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ
K951373 · Fujifilm Medical System U.S.A., Inc. · Oct 1995
KODAK AUTOMIXER II PLUS
K954484 · Eastman Kodak Company · Oct 1995