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510(k) K810254

1.5` FOCAL SPOT RESOLUTION PATTERN by Machlett Laboratories, Inc. — Product Code IXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1981
Date Received
January 30, 1981
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 Machlett Laboratories, Inc.

  • K813158 — RDP-2000 (January 19, 1982)
  • K802888 — RAYTHEON MEDICAL IMAGING (January 9, 1981)
  • K780969 — GAMMA CAMERA (June 27, 1978)

Other clearances for product code IXF

  • K865100 — TISSUE-EQUIVALENT BREAST SIMULATOR (January 12, 1987)
  • 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)