510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K072445Substantially Equivalent

Integrated Brachytherapy Unit - Digital

Nucletron BV, Columbia MD / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072445 is the FDA 510(k) clearance record for INTEGRATED BRACHYTHERAPY UNIT - DIGITAL, a class II device, cleared for Nucletron Corp. on under FDA product code KPQ (System, Simulation, Radiation Therapy). FDA records list 61 510(k) clearances for Nucletron Corp., from to . As of , FDA records show no recalls naming K072445.

Clearance record

Decision date
Received
(15 days to decision)
Product code
KPQ System, Simulation, Radiation Therapy
Regulation
21 CFR 892.5840
Device class
Class II
Review panel
Radiology
Applicant
Nucletron Corp. 8671 Robert Fulton Dr., Columbia MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KPQ

Trailing 12 months

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

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