FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sensus Healthcare TVM Balloon Applicator
K Number: K190255
·
Decision Feb 21, 2019
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
52
Applicant Total
4
Review Days
14
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Sensus Healthcare TVM Balloon Applicator
- K Number
- K190255
- 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
- February 7, 2019
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAD), ordered by most recent decision date.
GentleBeam (GB1000)
FDA 510(k)
FDA Class 2
·Radiology
INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)
FDA 510(k)
FDA Class 2
·Radiology
X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)
FDA 510(k)
FDA Class 2
·Radiology
Esteya
FDA 510(k)
FDA Class 2
·Radiology
Sensus IORT System
FDA 510(k)
FDA Class 2
·Radiology
SRT-100+
FDA 510(k)
FDA Class 2
·Radiology