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510(k) K012953

GIOTTO IMAGE by Medx, Inc. — Product Code IZH

K012953 is an FDA 510(k) premarket notification submitted by Medx, Inc. for the device "GIOTTO IMAGE". The FDA issued a decision of Substantially Equivalent on November 30, 2001. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Medx, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2001
Date Received
September 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

Other clearances by Medx, Inc.

  • K082581 — C-QUEST (November 14, 2008)
  • K073456 — T-QUEST SYSTEM (December 20, 2007)
  • K041840 — MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM (August 20, 2004)
  • K993893 — MEDX INTECAM INTERFACE (February 10, 2000)
  • K911666 — MEDX MACHINE (July 3, 1991)
  • K896553 — MEDX CERVICAL EXTENSION TEST & REHAB MACHINE (January 2, 1990)
  • K895236 — MEDX REHABILITATION MACHINE (September 14, 1989)
  • K884661 — D-SCOPE III (April 12, 1989)
  • K872127 — D-SCOPE II AND D-SCOPE IIC (June 18, 1987)
  • K870703 — SKAN D-SCOPE (February 26, 1987)

Other clearances for product code IZH

  • K203509 — SMART FINDER (July 14, 2021)
  • K202294 — Affirm Contrast Biopsy (October 5, 2020)
  • K191495 — Biopsy Positioner (July 3, 2019)
  • K161575 — Affirm Lateral Arm Upright Biopsy Accessory (August 10, 2016)
  • K161920 — Comfort Cover (July 15, 2016)
  • K153486 — Affirm Prone Biopsy System (April 1, 2016)
  • K152038 — MammoGRIP (December 22, 2015)
  • K123414 — SPECBOARD JR. (January 11, 2013)
  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (January 11, 2013)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)

FDA data resources