510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K973848Substantially Equivalent

Ibu, Integrated Brachy Therapy Unit

Nucletron BV, Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973848 is the FDA 510(k) clearance record for IBU, INTEGRATED BRACHY THERAPY UNIT, 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 K973848.

Clearance record

Decision date
Received
(106 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. 7080 Columbia Gateway Dr., Columbia MD
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPQ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260