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510(k) K955411

DELTA 16 by Instrumentarium Imaging, Inc. — Product Code IZH

K955411 is an FDA 510(k) premarket notification submitted by Instrumentarium Imaging, Inc. for the device "DELTA 16". The FDA issued a decision of Substantially Equivalent on March 21, 1996. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Instrumentarium Imaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1996
Date Received
November 27, 1995
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.

  • K002472 — DELTA 32 AND DELTA 32 TACT (November 29, 2000)
  • 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)
  • 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)
  • K923352 — INSTRUMENTARIUM MEGA4 HT (October 6, 1992)

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