P2020-8-0 BEAM-LIMITING DEVICE
FDA 510(k) clearance K914184 · decided 1991-11-27
Clearance details
- K-number
- K914184
- Device name
- P2020-8-0 BEAM-LIMITING DEVICE
- Applicant
- Precise Optics
- Decision
- Substantially Equivalent
- Date received
- 1991-09-18
- Decision date
- 1991-11-27
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- KPW
- Device class
- 2
- Regulation number
- 892.1610
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bay Shore, 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.
| Record | Firm | Date |
|---|---|---|
| LUMOS, MODEL R 72B (K093596) | Lumos, Inc. | 2010-01-12 |
| COLLIMATOR, MODEL M-38 (K062788) | Umi International | 2006-12-28 |
| R 72 (K030487) | Ralco S.R.L. | 2003-08-01 |
| BLA-800A (K954310) | Toshiba Medical Systems | 1995-10-18 |
| R 302 (K946320) | Ralco S.R.L. | 1995-05-11 |
| DENSICOMP 250 (K904587) | L. Keroack Co. | 1991-01-24 |
| TF-63SA (K904044) | Toshiba America Medical Systems, In.C | 1990-11-29 |
| EUREKA EXTENSION CYLINDERS (K904489) | Eureka X-Ray Tube Corp. | 1990-10-15 |
| RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC (K820306) | Tecnomed, Inc. | 1982-03-05 |
| RALCO COLLIMATORS, MANUAL RADIOGRAPHIC (K820305) | Tecnomed, Inc. | 1982-03-04 |
| PODIOSCOPE BY ARROW (K820119) | Arrow X-Ray Corp. | 1982-02-18 |
| ALUMINUM FILTRATION SYSTEM (K811450) | Wedge Filtration System | 1981-07-02 |
Recalls involving this device
No recalls on record reference this clearance.