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510(k) K921962

LORAD DIGITAL SPOT MAMMOGRAPHY by Lorad Medical Systems, Inc. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1992
Date Received
April 27, 1992
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 Lorad Medical Systems, Inc.

  • K922619 — DIGITIZER, MODEL # 3-000A-1518 (July 1, 1992)
  • K913732 — MAMMOGRAPHIC X-RAY SYSTEM (February 3, 1992)
  • K913478 — RADIOGRAPHIC FILM MARKING SYSTEM (October 15, 1991)
  • K894935 — S-70 PORTABLE DENTAL X-RAY SYSTEM (April 25, 1990)
  • K894643 — RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT (December 14, 1989)
  • K882875 — STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY (November 7, 1988)
  • K842102 — LORAD (July 17, 1984)

Other clearances for product code IZH

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  • 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)
  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (January 11, 2013)
  • K123414 — SPECBOARD JR. (January 11, 2013)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)