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510(k) K021113

MAMMOPATH by Fischer Imaging Corp. — Product Code MWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2002
Date Received
April 5, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cabinet, X-Ray System
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Fischer Imaging Corp.

  • K042095 — MAMMOTEST (October 29, 2004)
  • 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)
  • K944150 — MICRO X-65 HF (September 16, 1994)
  • K944148 — MICRO X-30HF (September 16, 1994)

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