LEKSELL STEREOTACTIC SYSTEM
FDA 510(k) clearance K802140 · decided 1981-02-05
Clearance details
- K-number
- K802140
- Device name
- LEKSELL STEREOTACTIC SYSTEM
- Applicant
- Downs Surgical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1980-09-04
- Decision date
- 1981-02-05
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- IWY
- Device class
- 1
- Regulation number
- 892.1920
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, 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.
| Record | Firm | Date |
|---|---|---|
| ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM (K925705) | Denar Corp. | 1992-12-28 |
| HEAD HOLDING DEVICE/SLEEP APNEA (K884493) | X-Ray Systems | 1989-01-12 |
| MTD HEDREST (K884847) | Composites Horizons, Inc. | 1989-01-09 |
| DUOCEPH (K864527) | Gary E. Hall, Dds | 1987-01-07 |
| KELLER CEPHALOMETRIC DEVICE (K850197) | Gary D. Keller | 1985-03-22 |
| HEAD-SPINE STABILIZER HSS-1 (K844549) | Imaging Accessories, Inc. | 1985-03-01 |
| PORTA-STAT (K843340) | Porta-Stat, Inc. | 1984-11-27 |
| DELUXE WALL-MOUNTED CEPHALOMETER (K834559) | Knochen Dental Laboratory | 1984-02-21 |
| X-RAY CO-ORDINATOR (K772313) | Rinn Corp. | 1978-01-30 |
Recalls involving this device
No recalls on record reference this clearance.