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510(k) K873836

MAMMOGRAPHIC KVP METER MODEL 232 by Radiation Measurements, Inc. — Product Code IZH

K873836 is an FDA 510(k) premarket notification submitted by Radiation Measurements, Inc. for the device "MAMMOGRAPHIC KVP METER MODEL 232". The FDA issued a decision of Substantially Equivalent on October 16, 1987. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Radiation Measurements, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1987
Date Received
September 21, 1987
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 Radiation Measurements, Inc.

  • K893216 — RMI ULTRASOUND DOPPLER PHANTOM SYSTEM (September 5, 1989)
  • K885223 — RMI SHORT DISTANCE ALIGNMENT DEVICE (February 17, 1989)
  • K873956 — ULTIMETER (October 30, 1987)
  • K854976 — RMI RESPIRATORY GATING SYSTEM MODEL 301 (May 7, 1986)
  • K834483 — DIGI-X (March 5, 1984)
  • K834607 — ELECTRONIC KVP CASSETTE (February 21, 1984)
  • K834481 — DOPPLER PHANTOM FLOW CONTROL SYS (January 25, 1984)
  • K834482 — TISSUE MIMICKING ULTRASOUND PHANTOMS (January 25, 1984)
  • K837033 — ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440 (March 9, 1983)
  • K812949 — RMI TRANSILLUMINATOR, MODEL 292 (December 2, 1981)

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