SUMITOMO PROTON THERAPY SYSTEM
FDA 510(k) clearance K130426 · decided 2013-11-19
Clearance details
- K-number
- K130426
- Device name
- SUMITOMO PROTON THERAPY SYSTEM
- Applicant
- Sumitomo Heavy Industries, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-02-20
- Decision date
- 2013-11-19
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- LHN
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.