FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM
K Number: K073059
·
Decision Dec 10, 2007
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
2
Review Days
41
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Basic Information
- Device Name
- PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM
- K Number
- K073059
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hitachi, Ltd., Power Systems Group
- Date Received
- October 30, 2007
- Decision Date
- December 10, 2007
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LHN), ordered by most recent decision date.
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Other Clearances by Hitachi, Ltd., Power Systems Group
| K Number | Device Name | ||
|---|---|---|---|
| K053280 | PROBEAT | Mar 9, 2006 | Substantially Equivalent |