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510(k) K901997

X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS by Comet Ltd. C/O Radiology Resources, Inc. — Product Code IZH

K901997 is an FDA 510(k) premarket notification submitted by Comet Ltd. C/O Radiology Resources, Inc. for the device "X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS". The FDA issued a decision of Substantially Equivalent on June 6, 1990. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Comet Ltd. C/O Radiology Resources, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1990
Date Received
May 2, 1990
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 Comet Ltd. C/O Radiology Resources, Inc.

  • K912338 — TUBE HOUSING ASSEMBLIES (August 7, 1991)
  • K911695 — VARIOUS X-RAY TUBES (June 19, 1991)
  • K910842 — DI2000/HS-45-150 X-RAY TUBE INSERT (March 6, 1991)
  • K864749 — TELAMAT (February 10, 1987)

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