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510(k) K910111

VARIOUS MODELS OF DAYLIGHT CASSETTE HOLDERS by Instrumentarium Imaging, Inc. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1991
Date Received
January 10, 1991
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 Imaging, Inc.

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  • K001928 — SIGMA (August 2, 2000)
  • K000976 — DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) (June 1, 2000)
  • K001171 — DELTA 16 TACT (May 12, 2000)
  • K973642 — ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 (November 21, 1997)
  • K955411 — DELTA 16 (March 21, 1996)
  • K925987 — INSTRUMENTARIUM MEGA4 HT (May 19, 1993)
  • K924921 — INSTRUMENTARIUM MEGA4 HT (May 17, 1993)
  • K923581 — INSTRUMENTARIUM MEGA4 HT (May 3, 1993)
  • K924472 — INSTRUMENTARIUM MEGA4 HT (May 3, 1993)

Other clearances for product code IZH

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  • 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)