Home / 510(k) Clearances / K865100

510(k) K865100

TISSUE-EQUIVALENT BREAST SIMULATOR by Computerized Imaging Reference Systems, Inc. — Product Code IXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1987
Date Received
December 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test-Pattern, Radiographic
Device Class
Class I
Regulation Number
892.1940
Review Panel
RA
Submission Type

Other clearances by Computerized Imaging Reference Systems, Inc.

  • K852528 — BONE DENSITY CT PHANTOM (September 26, 1985)

Other clearances for product code IXF

  • K851812 — DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711 (June 5, 1985)
  • K834482 — TISSUE MIMICKING ULTRASOUND PHANTOMS (January 25, 1984)
  • K834481 — DOPPLER PHANTOM FLOW CONTROL SYS (January 25, 1984)
  • K810254 — 1.5` FOCAL SPOT RESOLUTION PATTERN (February 19, 1981)