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510(k) K884345

MODEL ESP-200 MAMMOGRAPHIC SYSTEM by Acoma Medical Imaging, Inc. — Product Code IZH

K884345 is an FDA 510(k) premarket notification submitted by Acoma Medical Imaging, Inc. for the device "MODEL ESP-200 MAMMOGRAPHIC SYSTEM". The FDA issued a decision of Substantially Equivalent on March 23, 1989. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Acoma Medical Imaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1989
Date Received
October 14, 1988
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 Acoma Medical Imaging, Inc.

  • K981227 — SYMPHONY 360 REMOTE CONTROL TABLE (June 30, 1998)
  • K981131 — PATHFINDER MOBILE C ARM (June 26, 1998)
  • K963851 — TILTING RADIOGRAPHIC TABLE (REMOTE) (January 23, 1997)
  • K944952 — ANGIOGRAPHIC SYSTEM (February 17, 1995)
  • K941017 — F/C/W TUBESTAND (July 29, 1994)
  • K941004 — CTS SYSTEM (July 29, 1994)
  • K925598 — BUCKYMATIC AUTOMATIC CHEST FILM CHANGER (February 1, 1993)
  • K921116 — PX-100 PORTABLE X-RAY GENERATOR (October 5, 1992)
  • K921425 — SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R (August 27, 1992)
  • K902637 — FUTURUS 2001 X-RAY GENERATOR (August 3, 1990)

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)
  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (January 11, 2013)
  • K123414 — SPECBOARD JR. (January 11, 2013)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)

FDA data resources