RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST
FDA premarket approval P860062/S002 · decided 1988-07-27
Approval details
- PMA number
- P860062
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST
- Generic name
- System, nuclear magnetic resonance imaging
- Applicant
- Resonex, Inc.
- Date received
- 1988-06-08
- Decision date
- 1988-07-27
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LNH
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Sunnyvale, CA
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 |
|---|---|---|
| FAST SPIN ECHO (FSE) (K935369) | Resonex, Inc. | 1994-03-21 |
| NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEM (K935570) | Resonex, Inc. | 1994-03-16 |
| ECG GATING UNIT (K931392) | Resonex, Inc. | 1993-11-02 |
| 3DTOF MRA (K923870) | Resonex, Inc. | 1993-01-12 |
| KINEMATIC MRI MOVIEMAKER (K924154) | Resonex, Inc. | 1992-11-23 |
| 3D IMAGING (K923823) | Resonex, Inc. | 1992-10-30 |
| MAGNETIZATION TRANSFER CONTRAST (K922677) | Resonex, Inc. | 1992-09-04 |
| COILS FOR RX4000 & RX5000 MRI SYSTEMS (K920254) | Resonex, Inc. | 1992-06-22 |