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510(k) K934478

ALPHA STEREO by Instrumentarium Corp. — Product Code IZH

K934478 is an FDA 510(k) premarket notification submitted by Instrumentarium Corp. for the device "ALPHA STEREO". The FDA issued a decision of Substantially Equivalent on January 31, 1995. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Instrumentarium Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1995
Date Received
September 14, 1993
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 Instrumentarium Corp.

  • K022630 — MODIFICATION TO FOCUS (October 9, 2002)
  • K001729 — FOCUS (July 13, 2000)
  • K001439 — ORTHOCEPH OC100 D (June 22, 2000)
  • K992385 — ORTHOPANTOMOGRAPH OP100D (September 28, 1999)
  • K981641 — MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA (July 17, 1998)
  • K962638 — TONOCAP, TC-200 AND ACCESSORY CATHETERS (April 4, 1997)
  • K961441 — TONOMETERED SLAINE BLOOD GAS CONTROL (April 30, 1996)
  • K955018 — TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR (January 30, 1996)
  • K923433 — AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE (July 22, 1993)
  • K930338 — ORTHOCEPH OC100 (April 27, 1993)

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