CINE CAMERA CONTROL MODEL PK2037
FDA 510(k) clearance K896615 · decided 1990-01-04
Clearance details
- K-number
- K896615
- Device name
- CINE CAMERA CONTROL MODEL PK2037
- Applicant
- Perkins Mfg. Co.
- Decision
- Substantially Equivalent
- Date received
- 1989-11-21
- Decision date
- 1990-01-04
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- IZJ
- Device class
- 2
- Regulation number
- 892.1620
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Dallas, TX, 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 |
|---|---|---|
| CCD CAMERA, MODEL PKP-06000-000 (K024085) | Perkins Electronics Co. | 2003-03-11 |
| DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR (K972130) | Fairmontmedical | 1997-10-09 |
| DSP OPTION (K945580) | Philips Medical Systems (Cleveland), Inc. | 1995-01-30 |
| PHILIPS DSI SYSTEM RELEASE 3.2 (K920793) | Philips Medical Systems, Inc. | 1992-07-17 |
| DTV-4114 FLUOROSCOPIC TELEVISION CAMERA (K881688) | Adac Laboratories | 1988-05-18 |
| CANON X-RAY 35MM CINE CAMERA CSI-35 (K853983) | Canon USA, Inc. | 1985-10-16 |
| VIDICAM 200 (K812613) | Diversified P.A. | 1981-12-08 |
| SIRCAM 103 (K810191) | Siemens Corp. | 1981-02-26 |
| 105MM ROLL FILM FLUOROGR. CAMERA, #105 (K810072) | Scientex Corp. | 1981-02-12 |
| 105MM SPOT FILM CAMERA (K802132) | Instrumentation Camera, Inc. | 1980-10-23 |
| SIRCAM 106 (K792394) | Siemens Corp. | 1979-12-20 |
Recalls involving this device
No recalls on record reference this clearance.