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510(k) K924345

RADIOGRAPHIC FILM MARKETING SYSTEM by Fischer Imaging Corp. — Product Code JAC

K924345 is an FDA 510(k) premarket notification submitted by Fischer Imaging Corp. for the device "RADIOGRAPHIC FILM MARKETING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 27, 1992. The device falls under product code JAC (System, X-Ray, Film Marking, Radiographic), a Class I device regulated under 21 CFR 892.1640. Fischer Imaging Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1992
Date Received
August 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Film Marking, Radiographic
Device Class
Class I
Regulation Number
892.1640
Review Panel
RA
Submission Type

Other clearances by Fischer Imaging Corp.

  • K042095 — MAMMOTEST (October 29, 2004)
  • K021113 — MAMMOPATH (June 13, 2002)
  • K981414 — LC POSITIONER (July 16, 1998)
  • K973400 — MAMMOTEST ADAPTER DRIVER (November 10, 1997)
  • K964806 — MD-1835 (March 4, 1997)
  • K961207 — EP-X BIPLANE (August 20, 1996)
  • K961022 — TANGENT VI TABLE (May 3, 1996)
  • K950291 — DIGITAL 625HF (March 23, 1995)
  • K945619 — ATHENA HFX (March 23, 1995)
  • K944149 — MICRO X-80 HF (September 16, 1994)

Other clearances for product code JAC

  • K942883 — DIGITAL I.D. CAMERA (September 30, 1994)
  • K930752 — CT/MRI TOPOGRAPHIC MARKER (November 19, 1993)
  • K932357 — FUJI EC ID CAMERA (July 26, 1993)
  • K925892 — SOLSTICE XRAY RING MARKER PAD (May 18, 1993)
  • K923533 — ADMARK (March 4, 1993)
  • K926404 — KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L (March 4, 1993)
  • K925332 — BENNETT X-RAY ID PLUS (November 27, 1992)
  • K920031 — KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE (February 12, 1992)
  • K915088 — KODAK MIN-R IDENTIFICATION CAMERA (December 2, 1991)
  • K913478 — RADIOGRAPHIC FILM MARKING SYSTEM (October 15, 1991)

FDA data resources