Cleared Traditional

Sensus TPS Workstation

K182665 · Sensus Healthcare, Inc. · Radiology
Feb 2019
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K182665 is an FDA 510(k) clearance for the Sensus TPS Workstation, a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Sensus Healthcare, Inc. (Boca Raton, US). The FDA issued a Cleared decision on February 21, 2019, 149 days after receiving the submission on September 25, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K182665 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2018
Decision Date February 21, 2019
Days to Decision 149 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUJ — System, Planning, Radiation Therapy Treatment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050