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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Underwriters Laboratories, Inc.
CAROLE STAMP

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IXW Processor, Radiographic-film, Automatic

All 81
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
MICRO-MAX, MODEL 319
K002404 · Tek Marketing, Inc. · Aug 2000
ALL-PRO 2010
K001321 · All-Pro Imaging Corp. · May 2000
KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR
K990969 · Konica Medical Corp. · Jun 1999
AII-PRO 100 PLUS AND ALL-PRO 200
K991435 · All-Pro Imaging Corp. · May 1999
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
K992818 · OPTIMAX/ COMPACT 2
Download PDF FDA Summary Protec GmbH & Co. KG