Product code IZJ— Radiology
105MM ROLL FILM FLUOROGR. CAMERA, #105
- Classification name
- Camera, X-Ray, Fluorographic, Cine Or Spot
- Device class
- Class 2
- Regulation
- 21 CFR 892.1620
- Advisory panel
- Radiology
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code IZJ
FDA has cleared devices under product code IZJ between 1979 and 2003, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2003
- 1997
- 1995
- 1992
- 1990
- 1988
- 1985
- 1981
- 1980
- 1979
Top applicants under product code IZJ
Recent clearances under product code IZJ
- K024085 — CCD CAMERA, MODEL PKP-06000-000
- K972130 — DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR
- K945580 — DSP OPTION
- K920793 — PHILIPS DSI SYSTEM RELEASE 3.2
- K896615 — CINE CAMERA CONTROL MODEL PK2037
- K881688 — DTV-4114 FLUOROSCOPIC TELEVISION CAMERA
- K853983 — CANON X-RAY 35MM CINE CAMERA CSI-35
- K812613 — VIDICAM 200
- K810191 — SIRCAM 103
- K810072 — 105MM ROLL FILM FLUOROGR. CAMERA, #105
- K802132 — 105MM SPOT FILM CAMERA
- K792394 — SIRCAM 106
Data sourced from openFDA. This site is unofficial and independent of the FDA.