DIASONICS NMR IMAGING SYSTEM
FDA premarket approval P830053/S025 · decided 1987-03-20
Approval details
- PMA number
- P830053
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIASONICS NMR IMAGING SYSTEM
- Generic name
- System, nuclear magnetic resonance imaging
- Applicant
- Diasonics, Inc.
- Date received
- 1987-02-19
- Decision date
- 1987-03-20
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LNH
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- S. San Francisco, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VINGMED SOUND COLOR FLOW MAPPING SYSTEM (K962662) | Diasonics, Inc. | 1997-01-02 |
| CFM-800 COLOR FLOW MAPPING SYSTEM (K924079) | Diasonics, Inc. | 1993-09-28 |
| CPA/3.5 MHZ PROBE (K911435) | Diasonics, Inc. | 1992-09-11 |
| SACA, 3.5 MHZ PROBE (K905200) | Diasonics, Inc. | 1992-04-02 |
| CW DOPPLER 2.25 MHZ PROBE (K903562) | Diasonics, Inc. | 1992-03-02 |
| CW DOPPLER/4.5 MHZ (K903984) | Diasonics, Inc. | 1991-06-14 |
| ACCESS(TM), SOFTWARE RELEASE 4.11P (K896637) | Diasonics, Inc. | 1990-01-22 |
| MT/S SOFTWARE RELEASE 5.0. (K893518) | Diasonics, Inc. | 1989-10-27 |