510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893216Substantially Equivalent

Rmi Ultrasound Doppler Phantom System

Radiation Measurements, Inc., Middleton WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893216 is the FDA 510(k) clearance record for RMI ULTRASOUND DOPPLER PHANTOM SYSTEM, a class I device, cleared for Radiation Measurements, Inc. on under FDA product code GXX (Block, Test, Ultrasonic Scanner Calibration). FDA records list 12 510(k) clearances for Radiation Measurements, Inc., from to . As of , FDA records show no recalls naming K893216.

Clearance record

Decision date
Received
(131 days to decision)
Product code
GXX Block, Test, Ultrasonic Scanner Calibration
Regulation
21 CFR 882.1925
Device class
Class I
Review panel
Neurology
Applicant
Radiation Measurements, Inc. P.O. Box 327, Middleton WI
Third party review
No

Clearances, product code GXX

Trailing 12 months

FDA records hold no clearances under product code GXX in the trailing twelve months.

FDA records show no clearances under product code GXX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260