Submission Details
| 510(k) Number | K182641 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 24, 2018 |
| Decision Date | February 21, 2019 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
Sensus IORT System
Feb 2019
Decision
150d
Days
Class 2
Risk
About This 510(k) Submission
K182641 is an FDA 510(k) clearance for the Sensus IORT System, a System, Therapeutic, X-ray (Class II — Special Controls, product code JAD), submitted by Sensus Healthcare, Inc. (Boca Raton, US). The FDA issued a Cleared decision on February 21, 2019, 150 days after receiving the submission on September 24, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5900.
Device Classification
| Product Code | JAD — System, Therapeutic, X-ray |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.5900 |
Manufacturer
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