510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K915367Substantially Equivalent

Hdrs-1 System

Precision Radiation Measurement, Inc., Nashville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915367 is the FDA 510(k) clearance record for HDRS-1 SYSTEM, a class II device, cleared for Precision Radiation Measurement, Inc. on under FDA product code JAQ (System, Applicator, Radionuclide, Remote-Controlled). FDA records list one 510(k) clearance for Precision Radiation Measurement, Inc. As of , FDA records show no recalls naming K915367.

Clearance record

Decision date
Received
(131 days to decision)
Product code
JAQ System, Applicator, Radionuclide, Remote-Controlled
Regulation
21 CFR 892.5700
Device class
Class II
Review panel
Radiology
Applicant
Precision Radiation Measurement, Inc. 1928 Elm Tree Dr., Nashville TN
510(k) summary
Statement
Third party review
No

Clearances, product code JAQ

Trailing 12 months
4 clearances under product code JAQ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAQ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260