TESLACON(TM) NMR IMAGING SYSTEM
FDA premarket approval P830051/S013 · decided 1986-10-22
Approval details
- PMA number
- P830051
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TESLACON(TM) NMR IMAGING SYSTEM
- Generic name
- System, nuclear magnetic resonance imaging
- Applicant
- Technicare Corp.
- Date received
- 1986-09-04
- Decision date
- 1986-10-22
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LNH
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Cleveland, OH
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| TECHNICARE 720 HPS CT SCANNER (K854340) | Technicare Corp. | 1985-11-15 |
| SATURN NUCLEAR MEDICINE COMPUTER SYSTEM (K852089) | Technicare Corp. | 1985-07-18 |
| AUTO DII MULTI FREQUENCY (K844293) | Technicare Corp. | 1985-02-13 |
| ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS (K844247) | Technicare Corp. | 1985-01-23 |
| NUCLEAR 700 MEDICINE MECHANICAL POSIT- (K843716) | Technicare Corp. | 1984-12-17 |
| AUTOFOCUS DUAL ELEMENT PROBE (K842777) | Technicare Corp. | 1984-11-29 |
| TECHNICARE 248 SL & 260SL (K841817) | Technicare Corp. | 1984-08-17 |
| CENTAURI CT SCANNER (K840860) | Technicare Corp. | 1984-05-22 |