Cleared Traditional

K141657 - THD REVOLUTION

K141657 is an FDA 510(k) clearance for THD REVOLUTION, manufactured by Thd Spa. The device is a Class 2 Radiology device with product code JAF cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K141657 · Thd Spa · Radiology device
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Optimized for regulatory review, auditing and printing
Feb 2015
Decision
249d
Days
Class 2
Risk

K141657 is an FDA 510(k) clearance for the THD REVOLUTION. Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Thd Spa (Imola, Bo, IT). The FDA issued a Cleared decision on February 24, 2015 after a review of 249 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1540 - 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 Thd Spa devices

FDA 510(k) Submission Details - K141657

510(k) Number K141657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2014
Decision Date February 24, 2015
Days to Decision 249 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 107d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAF Device Classification - Class 2, Special Controls

Product Code JAF Monitor, Ultrasonic, Nonfetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1540
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 Peers - JAF Monitor, Ultrasonic, Nonfetal

All 8
Devices cleared under the same product code (JAF) and FDA review panel - the closest regulatory comparables to K141657.
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