OPART MRT-600
FDA 510(k) clearance K962933 · decided 1996-10-25
Clearance details
- K-number
- K962933
- Device name
- OPART MRT-600
- Applicant
- Toshiba America Mri, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-29
- Decision date
- 1996-10-25
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- S. San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.