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510(k) K891090

SPECBOARD by Macbrud Corp. Medical Div. — Product Code IZH

K891090 is an FDA 510(k) premarket notification submitted by Macbrud Corp. Medical Div. for the device "SPECBOARD". The FDA issued a decision of Substantially Equivalent on April 7, 1989. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Macbrud Corp. Medical Div. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1989
Date Received
March 6, 1989
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 Macbrud Corp. Medical Div.

  • K913049 — SLIP-PRUF-CLINGER (September 11, 1991)
  • K911873 — X-MARX (July 19, 1991)
  • K900282 — NEEDLE-SHIELD (February 28, 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)
  • 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