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510(k) K001171

DELTA 16 TACT by Instrumentarium Imaging, Inc. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2000
Date Received
April 11, 2000
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 Instrumentarium Imaging, Inc.

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  • K001928 — SIGMA (August 2, 2000)
  • K000976 — DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) (June 1, 2000)
  • K973642 — ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 (November 21, 1997)
  • K955411 — DELTA 16 (March 21, 1996)
  • K925987 — INSTRUMENTARIUM MEGA4 HT (May 19, 1993)
  • K924921 — INSTRUMENTARIUM MEGA4 HT (May 17, 1993)
  • K924472 — INSTRUMENTARIUM MEGA4 HT (May 3, 1993)
  • K923581 — INSTRUMENTARIUM MEGA4 HT (May 3, 1993)
  • K923352 — INSTRUMENTARIUM MEGA4 HT (October 6, 1992)

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