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510(k) K834482

TISSUE MIMICKING ULTRASOUND PHANTOMS by Radiation Measurements, Inc. — Product Code IXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1984
Date Received
December 15, 1983
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 Radiation Measurements, Inc.

  • K893216 — RMI ULTRASOUND DOPPLER PHANTOM SYSTEM (September 5, 1989)
  • K885223 — RMI SHORT DISTANCE ALIGNMENT DEVICE (February 17, 1989)
  • K873956 — ULTIMETER (October 30, 1987)
  • K873836 — MAMMOGRAPHIC KVP METER MODEL 232 (October 16, 1987)
  • K854976 — RMI RESPIRATORY GATING SYSTEM MODEL 301 (May 7, 1986)
  • K834483 — DIGI-X (March 5, 1984)
  • K834607 — ELECTRONIC KVP CASSETTE (February 21, 1984)
  • K834481 — DOPPLER PHANTOM FLOW CONTROL SYS (January 25, 1984)
  • K837033 — ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440 (March 9, 1983)
  • K812949 — RMI TRANSILLUMINATOR, MODEL 292 (December 2, 1981)

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)
  • K834481 — DOPPLER PHANTOM FLOW CONTROL SYS (January 25, 1984)
  • K810254 — 1.5` FOCAL SPOT RESOLUTION PATTERN (February 19, 1981)