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510(k) K881688

DTV-4114 FLUOROSCOPIC TELEVISION CAMERA by Adac Laboratories — Product Code IZJ

K881688 is an FDA 510(k) premarket notification submitted by Adac Laboratories for the device "DTV-4114 FLUOROSCOPIC TELEVISION CAMERA". The FDA issued a decision of Substantially Equivalent on May 18, 1988. The device falls under product code IZJ (Camera, X-Ray, Fluorographic, Cine Or Spot), a Class II device regulated under 21 CFR 892.1620. Adac Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1988
Date Received
April 19, 1988
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 Adac Laboratories

  • K062298 — APOLLO GAMMA CAMERA SYSTEM (August 23, 2006)
  • K061029 — JETSTREAM WORKSPACE (May 1, 2006)
  • K060020 — AUTOQUANT PLUS (January 20, 2006)
  • K051351 — PRECEDENCE SPECT/CT IMAGING SYSTEM (June 8, 2005)
  • K042880 — JETSTREAM WORKSPACE (November 3, 2004)
  • K042903 — AUTOSPECS (October 29, 2004)
  • K041577 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (June 25, 2004)
  • K041218 — GRIFFIN SPECT/CT IMAGING SYSTEM (May 24, 2004)
  • K041182 — SYNTEGRA (May 21, 2004)
  • K040326 — AUTOQUANT PLUS (February 25, 2004)

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)
  • 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)
  • K802132 — 105MM SPOT FILM CAMERA (October 23, 1980)

FDA data resources