510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854976Substantially Equivalent

Rmi Respiratory Gating System Model 301

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

K854976 is the FDA 510(k) clearance record for RMI RESPIRATORY GATING SYSTEM MODEL 301, a class I device, cleared for Radiation Measurements, Inc. on under FDA product code IXO (Synchronizer, Ecg / Respirator, Radiographic). FDA records list 12 510(k) clearances for Radiation Measurements, Inc., from to . As of , FDA records show no recalls naming K854976.

Clearance record

Decision date
Received
(146 days to decision)
Product code
IXO Synchronizer, Ecg / Respirator, Radiographic
Regulation
21 CFR 892.1970
Device class
Class I
Review panel
Radiology
Applicant
Radiation Measurements, Inc. P.O. Box 327, Middleton WI
Third party review
No

Clearances, product code IXO

Trailing 12 months

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

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