Cleared Traditional

K770986 - FLEXI-THERM FILM (FDA 510(k) Clearance)

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

K770986 · E-Z-Em, Inc. · Radiology device
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Sep 1977
Decision
104d
Days
Class 3
Risk

K770986 is an FDA 510(k) clearance for the FLEXI-THERM FILM. Classified as System, Thermographic, Liquid Crystal, Powered (adjunctive Use) (product code KXZ), Class III - Premarket Approval.

Submitted by E-Z-Em, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1977 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2982 - 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 E-Z-Em, Inc. devices

Submission Details

510(k) Number K770986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1977
Decision Date September 12, 1977
Days to Decision 104 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KXZ System, Thermographic, Liquid Crystal, Powered (adjunctive Use)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 884.2982
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.