FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
PROBEAT-V
K Number: K152592
·
Decision Nov 2, 2015
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
4
Review Days
53
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Basic Information
- Device Name
- PROBEAT-V
- K Number
- K152592
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hitachi, Ltd., Health Care Company
- Date Received
- September 10, 2015
- Decision Date
- November 2, 2015
- Product Code
- LHN
- 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 |
|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | FDA class 2 | Radiology |
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