Home / 510(k) Clearances / K021113

510(k) K021113

MAMMOPATH by Fischer Imaging Corp. — Product Code MWP

K021113 is an FDA 510(k) premarket notification submitted by Fischer Imaging Corp. for the device "MAMMOPATH". The FDA issued a decision of Substantially Equivalent on June 13, 2002. The device falls under product code MWP (Cabinet, X-Ray System), a Class II device regulated under 21 CFR 892.1680. Fischer Imaging Corp. has at least 10 other 510(k) clearances on record.

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)
  • K944149 — MICRO X-80 HF (September 16, 1994)
  • K944150 — MICRO X-65 HF (September 16, 1994)

Other clearances for product code MWP

  • K230136 — TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) (April 24, 2023)
  • K230140 — TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-U (April 24, 2023)
  • K213691 — Solas OR (December 22, 2021)
  • K210955 — Kubtec Mozart Supra (XPERT 84) Radiography System (September 20, 2021)
  • K210957 — Kubec Xpert 80 Radiography System (August 31, 2021)
  • K210956 — Kubtec Mozart (XPERT42) (August 31, 2021)
  • K202713 — TrueView 100 Pro (November 18, 2020)
  • K200756 — Kubtec Mozart Supra (June 12, 2020)
  • K192939 — Volumetric Specimen Imager (December 27, 2019)
  • K193317 — CoreLite X-Ray Specimen Cabinet (December 13, 2019)

FDA data resources