INSTRUMENTARIUM ULF MR IMAGING SYSTEM
FDA premarket approval P860010/S003 · decided 1988-06-12
Approval details
- PMA number
- P860010
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- INSTRUMENTARIUM ULF MR IMAGING SYSTEM
- Generic name
- System, nuclear magnetic resonance imaging
- Applicant
- Palomex Instrumentarium Corp.
- Date received
- 1988-01-20
- Decision date
- 1988-06-12
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- LNH
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Helsinki, TX
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE (K872734) | Palomex Instrumentarium Corp. | 1987-10-08 |