ACCESS(TM), SOFTWARE RELEASE 4.11P
FDA 510(k) clearance K896637 · decided 1990-01-22
Clearance details
- K-number
- K896637
- Device name
- ACCESS(TM), SOFTWARE RELEASE 4.11P
- Applicant
- Diasonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-11-24
- Decision date
- 1990-01-22
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DIASONICS NMR IMAGING SYSTEM (P830053/S030) | Diasonics, Inc. | 1988-07-27 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S029) | Diasonics, Inc. | 1988-07-07 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S028) | Diasonics, Inc. | 1988-03-03 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S026) | Diasonics, Inc. | 1987-07-13 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S027) | Diasonics, Inc. | 1987-06-22 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S022) | Diasonics, Inc. | 1987-03-30 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S025) | Diasonics, Inc. | 1987-03-20 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S024) | Diasonics, Inc. | 1987-03-17 |