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510(k) K834483

DIGI-X by Radiation Measurements, Inc. — Product Code LHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1984
Date Received
December 6, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Quality-Assurance, Radiologic
Device Class
Class I
Regulation Number
892.1940
Review Panel
RA
Submission Type

Other clearances by Radiation Measurements, Inc.

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  • K873836 — MAMMOGRAPHIC KVP METER MODEL 232 (October 16, 1987)
  • K854976 — RMI RESPIRATORY GATING SYSTEM MODEL 301 (May 7, 1986)
  • K834607 — ELECTRONIC KVP CASSETTE (February 21, 1984)
  • K834482 — TISSUE MIMICKING ULTRASOUND PHANTOMS (January 25, 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)

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  • K860260 — MULTI PURPOSE MODEL 76-903 (May 7, 1986)
  • K860100 — MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902 (April 22, 1986)
  • K844620 — BDS-3 BEAM DATA SCANNER (July 1, 1985)
  • K845007 — RFA-7 RADIATION FIELD ANALYZER (July 1, 1985)