Cleared Traditional

THD REVOLUTION

K141657 · Thd Spa · Radiology
Feb 2015
Decision
249d
Days
Class 2
Risk

About This 510(k) Submission

K141657 is an FDA 510(k) clearance for the THD REVOLUTION, a Monitor, Ultrasonic, Nonfetal (Class II — Special Controls, product code JAF), submitted by Thd Spa (Imola, Bo, IT). The FDA issued a Cleared decision on February 24, 2015, 249 days after receiving the submission on June 20, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1540.

Submission Details

510(k) Number K141657 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code JAF — Monitor, Ultrasonic, Nonfetal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1540