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510(k) K864958

ALPHA II DIAGNOSTIC X-RAY by Ausonics Pty , Ltd. — Product Code IZH

K864958 is an FDA 510(k) premarket notification submitted by Ausonics Pty , Ltd. for the device "ALPHA II DIAGNOSTIC X-RAY". The FDA issued a decision of Substantially Equivalent on January 30, 1987. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Ausonics Pty , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1987
Date Received
December 18, 1986
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 Ausonics Pty , Ltd.

  • K933916 — AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER (October 3, 1994)
  • K915715 — CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER (July 2, 1992)
  • K920307 — AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION (May 19, 1992)
  • K905488 — DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN (December 18, 1991)
  • K902728 — 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) (February 13, 1991)
  • K896714 — AUSONICS 5000 (June 11, 1990)
  • K881979 — RESUBMITTAL OF MI 1000C MICROIMAGER (June 12, 1989)
  • K884299 — APA-C CATALOG NUMBER A-8001-C (January 10, 1989)
  • K883925 — UROIMAGER (December 15, 1988)
  • K883079 — WWDS-005 HUMAN RECTAL PROBE (December 14, 1988)

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