3D IMAGING
FDA 510(k) clearance K923823 · decided 1992-10-30
Clearance details
- K-number
- K923823
- Device name
- 3D IMAGING
- Applicant
- Resonex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-30
- Decision date
- 1992-10-30
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST (P860062/S002) | Resonex, Inc. | 1988-07-27 |
| RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST (P860062/S001) | Resonex, Inc. | 1988-05-25 |