510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961321Substantially Equivalent

Gamma Guidance System

Radiation Monitoring Devices, Inc., Watertown MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961321 is the FDA 510(k) clearance record for GAMMA GUIDANCE SYSTEM, a class I device, cleared for Radiation Monitoring Devices, Inc. on under FDA product code IZD (Probe, Uptake, Nuclear). FDA records list 2 510(k) clearances for Radiation Monitoring Devices, Inc., from to . As of , FDA records show no recalls naming K961321.

Clearance record

Decision date
Received
(311 days to decision)
Product code
IZD Probe, Uptake, Nuclear
Regulation
21 CFR 892.1320
Device class
Class I
Review panel
Radiology
Applicant
Radiation Monitoring Devices, Inc. 44 Hunt St., Watertown MA
510(k) summary
Statement
Third party review
No

Clearances, product code IZD

Trailing 12 months

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

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