Home / 510(k) Clearances / K983313

510(k) K983313

ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY by Elscint, Inc. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1998
Date Received
September 21, 1998
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 Elscint, Inc.

  • K982060 — VOLUMAX CT IMAGING SYSTEM (September 2, 1998)
  • K974344 — CT SCOPE (June 3, 1998)
  • K980306 — GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP (April 2, 1998)
  • K974614 — GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG (March 4, 1998)
  • K972592 — 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) (September 15, 1997)
  • K970680 — GLORY (June 20, 1997)
  • K965044 — GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326 (June 16, 1997)
  • K970980 — CARDIAC SCORING FOR CT SCANNERS (May 29, 1997)
  • K970005 — GYREX 2T-PRESTIGE (March 28, 1997)
  • K964583 — XRT-7.0 (January 17, 1997)

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)