Cleared Traditional

K971956 - CRT2000 THERMOGRAPHIC SYSTEM

K971956 is an FDA 510(k) clearance for CRT2000 THERMOGRAPHIC SYSTEM, manufactured by Werner Eidam Medizin-Technologie GmbH. The device is a Class 1 Radiology device with product code LHQ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K971956 · Werner Eidam Medizin-Technologie GmbH · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
87d
Days
Class 1
Risk

K971956 is an FDA 510(k) clearance for the CRT2000 THERMOGRAPHIC SYSTEM. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Werner Eidam Medizin-Technologie GmbH (Washington, US). The FDA issued a Cleared decision on August 22, 1997 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2980 - 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 - K971956

510(k) Number K971956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1997
Decision Date August 22, 1997
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

LHQ Device Classification - Class 1, General Controls

Product Code LHQ System, Telethermographic (adjunctive Use)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.2980
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LHQ System, Telethermographic (adjunctive Use)

All 33
Devices cleared under the same product code (LHQ) and FDA review panel - the closest regulatory comparables to K971956.
OMNICORDER BIOSCAN SYSTEM
K990416 · Omnicorder Technologies, Inc. · Dec 1999
THERMATREK IRIS-3 INFRARED IMAGING SYSTEM
K982112 · Thermatrek, Inc. · Aug 1998
INFRAMETRICS INFRACAM-MED
K982327 · Inframetrics, Inc. · Aug 1998
OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)
K951806 · Opgal Optronic Industries · Jul 1995
BSI MODEL TIP
K897191 · Bales Scientific, Inc. · Jul 1990
THERMO-5000
K895358 · Medtronix Ltd., Inc. · May 1990
K971956 · CRT2000 THERMOGRAPHIC SYSTEM
Download PDF FDA Summary Werner Eidam Medizin-…