Sensus IORT System— 510(k) K182641
Substantially EquivalentSensus Healthcare, Inc.
FDA 510(k) clearance K182641 for Sensus IORT System, Substantially Equivalent on 2019-02-21. Applicant: Sensus Healthcare, Inc.. Device class: 2.
Clearance details
- Applicant
- Sensus Healthcare, Inc.
- Product code
- Code JAD
- Device class
- Class 2
- Regulation
- 21 CFR 892.5900
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boca Raton, FL, US
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