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510(k) K882875

STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY by Lorad Medical Systems, Inc. — Product Code IZH

K882875 is an FDA 510(k) premarket notification submitted by Lorad Medical Systems, Inc. for the device "STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY". The FDA issued a decision of Substantially Equivalent on November 7, 1988. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Lorad Medical Systems, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1988
Date Received
July 11, 1988
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.

  • K921962 — LORAD DIGITAL SPOT MAMMOGRAPHY (November 23, 1992)
  • 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)
  • K842102 — LORAD (July 17, 1984)

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