FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROBEAT WITH MGCS
K Number: K060834
·
Decision Apr 19, 2006
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
8
Review Days
23
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Basic Information
- Device Name
- PROBEAT WITH MGCS
- K Number
- K060834
- 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.
- Date Received
- March 27, 2006
- Decision Date
- April 19, 2006
- 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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Other Clearances by Hitachi , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K201042 | PROBEAT-CR | Jul 13, 2020 | Substantially Equivalent |
| K191801 | PROBEAT-CR | Sep 13, 2019 | Substantially Equivalent |
| K172087 | SANGRAY | Oct 27, 2017 | Substantially Equivalent |
| K163505 | ARIETTA PRECISION | May 30, 2017 | Substantially Equivalent |
| K162902 | ARIETTA Prologue Diagnostic Ultrasound system and Transducers | Dec 15, 2016 | Substantially Equivalent |
| K162583 | ALOKA LISENDO 880 | Nov 17, 2016 | Substantially Equivalent |
| K161163 | PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory | Jul 13, 2016 | Substantially Equivalent |