ULTIMATE 3000
FDA 510(k) clearance K910839 · decided 1991-07-26
Clearance details
- K-number
- K910839
- Device name
- ULTIMATE 3000
- Applicant
- Fonar Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-02-27
- Decision date
- 1991-07-26
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Melville, NY, 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 |
|---|---|---|
| FONAR NMR WHOLE BODY SCANNER BETA 3000 (P830076/S012) | Fonar Corp. | 1988-07-12 |
| FONAR NMR WHOLE BODY SCANNER BETA 3000 (P830076/S013) | Fonar Corp. | 1988-05-24 |
| FONAR NMR WHOLE BODY SCANNER BETA 3000 (P830076/S009) | Fonar Corp. | 1988-04-15 |
| FONAR NMR WHOLE BODY SCANNER BETA 3000 (P830076/S011) | Fonar Corp. | 1988-04-12 |
| FONAR NMR WHOLE BODY SCANNER BETA 3000 (P830076/S010) | Fonar Corp. | 1988-04-12 |
| FONAR NMR WHOLE BODY SCANNER BETA 3000 (P830076/S008) | Fonar Corp. | 1987-06-22 |
| FONAR NMR WHOLE BODY SCANNER BETA 3000 (P830076/S007) | Fonar Corp. | 1986-12-05 |
| FONAR NMR WHOLE BODY SCANNER BETA 3000 (P830076/S006) | Fonar Corp. | 1986-11-28 |