SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH
FDA 510(k) clearance K955253 · decided 1996-01-26
Clearance details
- K-number
- K955253
- Device name
- SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH
- Applicant
- Shimadzu Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1995-11-13
- Decision date
- 1996-01-26
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Torrance, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.