510(k) K802132
- Device
- 105MM SPOT FILM CAMERA
- Applicant
- INSTRUMENTATION CAMERA, INC.
- 510(k) number
- K802132
- Product code
- IZJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-10-23
- Date received
- 1980-09-03
- Regulation
- 892.1620
- Classification name
- Camera, X-ray, Fluorographic, Cine Or Spot
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IZJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K024085 | CCD CAMERA, MODEL PKP-06000-000 | Perkins Electronics Co. | 2003-03-11 |
| K972130 | DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR | Fairmontmedical | 1997-10-09 |
| K945580 | DSP OPTION | Philips Medical Systems (Cleveland), Inc. | 1995-01-30 |
| K920793 | PHILIPS DSI SYSTEM RELEASE 3.2 | Philips Medical Systems, Inc. | 1992-07-17 |
| K896615 | CINE CAMERA CONTROL MODEL PK2037 | Perkins Mfg. Co. | 1990-01-04 |
| K881688 | DTV-4114 FLUOROSCOPIC TELEVISION CAMERA | Adac Laboratories | 1988-05-18 |
| K853983 | CANON X-RAY 35MM CINE CAMERA CSI-35 | Canon USA, Inc. | 1985-10-16 |
| K812613 | VIDICAM 200 | Diversified P.A. | 1981-12-08 |
| K810191 | SIRCAM 103 | Siemens Corp. | 1981-02-26 |
| K810072 | 105MM ROLL FILM FLUOROGR. CAMERA, #105 | Scientex Corp. | 1981-02-12 |
| K792394 | SIRCAM 106 | Siemens Corp. | 1979-12-20 |
Legacy Summary#
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FDA Review#
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