Cleared Traditional

K781455 - SIEMENS ULTRATHERM 708

K781455 is an FDA 510(k) clearance for SIEMENS ULTRATHERM 708, manufactured by Elmed, Inc.. The device is a Class 2 Radiology device with product code IMJ cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K781455 · Elmed, Inc. · Radiology device
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Dec 1978
Decision
106d
Days
Class 2
Risk

K781455 is an FDA 510(k) clearance for the SIEMENS ULTRATHERM 708. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by Elmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 7, 1978 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 890.5290 - 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: Standard predicate-based submission. Standard predicate reliance. 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 Elmed, Inc. devices

FDA 510(k) Submission Details - K781455

510(k) Number K781455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1978
Decision Date December 07, 1978
Days to Decision 106 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 107d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMJ Device Classification - Class 2, Special Controls

Product Code IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5290
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.