Cleared Traditional

K852950 - VISITHERM (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K852950 · C.D. Regelin & Associates, Inc. · Radiology device
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Feb 1986
Decision
211d
Days
Class 3
Risk

K852950 is an FDA 510(k) clearance for the VISITHERM. Classified as System, Telethermographic, Infrared (product code IYM), Class III - Premarket Approval.

Submitted by C.D. Regelin & Associates, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on February 7, 1986 after a review of 211 days - an extended review 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all C.D. Regelin & Associates, Inc. devices

Submission Details

510(k) Number K852950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1985
Decision Date February 07, 1986
Days to Decision 211 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 107d · This submission: 211d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYM System, Telethermographic, Infrared
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 884.2980
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.