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510(k) K802132

105MM SPOT FILM CAMERA by Instrumentation Camera, Inc. — Product Code IZJ

K802132 is an FDA 510(k) premarket notification submitted by Instrumentation Camera, Inc. for the device "105MM SPOT FILM CAMERA". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code IZJ (Camera, X-Ray, Fluorographic, Cine Or Spot), a Class II device regulated under 21 CFR 892.1620. Instrumentation Camera, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1980
Date Received
September 3, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, X-Ray, Fluorographic, Cine Or Spot
Device Class
Class II
Regulation Number
892.1620
Review Panel
RA
Submission Type

Other clearances by Instrumentation Camera, Inc.

  • K810716 — X-RAY IMAGE INTENSIFIER PRODUCTS (April 23, 1981)

Other clearances for product code IZJ

  • K024085 — CCD CAMERA, MODEL PKP-06000-000 (March 11, 2003)
  • K972130 — DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSAB (October 9, 1997)
  • K945580 — DSP OPTION (January 30, 1995)
  • K920793 — PHILIPS DSI SYSTEM RELEASE 3.2 (July 17, 1992)
  • K896615 — CINE CAMERA CONTROL MODEL PK2037 (January 4, 1990)
  • K881688 — DTV-4114 FLUOROSCOPIC TELEVISION CAMERA (May 18, 1988)
  • K853983 — CANON X-RAY 35MM CINE CAMERA CSI-35 (October 16, 1985)
  • K812613 — VIDICAM 200 (December 8, 1981)
  • K810191 — SIRCAM 103 (February 26, 1981)
  • K810072 — 105MM ROLL FILM FLUOROGR. CAMERA, #105 (February 12, 1981)

FDA data resources