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510(k) K837033

ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440 by Radiation Measurements, Inc.

K837033 is an FDA 510(k) premarket notification submitted by Radiation Measurements, Inc. for the device "ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440". The FDA issued a decision of Substantially Equivalent on March 9, 1983. Radiation Measurements, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1983
Date Received
December 14, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K834482 — TISSUE MIMICKING ULTRASOUND PHANTOMS (January 25, 1984)
  • K812949 — RMI TRANSILLUMINATOR, MODEL 292 (December 2, 1981)

FDA data resources