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510(k) K893216

RMI ULTRASOUND DOPPLER PHANTOM SYSTEM by Radiation Measurements, Inc. — Product Code GXX

K893216 is an FDA 510(k) premarket notification submitted by Radiation Measurements, Inc. for the device "RMI ULTRASOUND DOPPLER PHANTOM SYSTEM". The FDA issued a decision of Substantially Equivalent on September 5, 1989. The device falls under product code GXX (Block, Test, Ultrasonic Scanner Calibration), a Class I device regulated under 21 CFR 882.1925. Radiation Measurements, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1989
Date Received
April 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Test, Ultrasonic Scanner Calibration
Device Class
Class I
Regulation Number
882.1925
Review Panel
NE
Submission Type

Other clearances by Radiation Measurements, Inc.

  • 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)
  • K837033 — ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440 (March 9, 1983)
  • K812949 — RMI TRANSILLUMINATOR, MODEL 292 (December 2, 1981)

Other clearances for product code GXX

  • K844247 — ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS (January 23, 1985)
  • K844120 — ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS (January 23, 1985)

FDA data resources