FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sensus IORT System
K Number: K182641
·
Decision Feb 21, 2019
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
52
Applicant Total
4
Review Days
150
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Basic Information
- Device Name
- Sensus IORT System
- K Number
- K182641
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sensus Healthcare, Inc.
- Date Received
- September 24, 2018
- Decision Date
- February 21, 2019
- Product Code
- JAD
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAD | System, Therapeutic, X-Ray | FDA class 2 | Radiology |
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