510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834482Substantially Equivalent

Tissue Mimicking Ultrasound Phantoms

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

K834482 is the FDA 510(k) clearance record for TISSUE MIMICKING ULTRASOUND PHANTOMS, a class I device, cleared for Radiation Measurements, Inc. on under FDA product code IXF (Test-Pattern, Radiographic). FDA records list 12 510(k) clearances for Radiation Measurements, Inc., from to . As of , FDA records show no recalls naming K834482.

Clearance record

Decision date
Received
(41 days to decision)
Product code
IXF Test-Pattern, Radiographic
Regulation
21 CFR 892.1940
Device class
Class I
Review panel
Radiology
Applicant
Radiation Measurements, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code IXF

Trailing 12 months

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

FDA records show no clearances under product code IXF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IXF, 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