MODEL 580 DIGITAL RADIOGRAPHY SYSTEM
FDA 510(k) clearance K827501 · decided 1982-06-09
Clearance details
- K-number
- K827501
- Device name
- MODEL 580 DIGITAL RADIOGRAPHY SYSTEM
- Applicant
- Technicare Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-05-10
- Decision date
- 1982-06-09
- Days to decision
- 30 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Solon, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S015) | Technicare Corp. | 1988-07-14 |
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S014) | Technicare Corp. | 1987-08-26 |
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S011) | Technicare Corp. | 1986-11-14 |
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S012) | Technicare Corp. | 1986-11-05 |
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S013) | Technicare Corp. | 1986-10-22 |
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S009) | Technicare Corp. | 1986-10-01 |
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S007) | Technicare Corp. | 1986-10-01 |
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S010) | Technicare Corp. | 1986-10-01 |