510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K964206Substantially Equivalent

Nucletron Plato External Beam Planning Rts V2 and Rts 3D V2

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

K964206 is the FDA 510(k) clearance record for NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2, a class II device, cleared for Nucletron Corp. on under FDA product code IYE (Accelerator, Linear, Medical). FDA records list 61 510(k) clearances for Nucletron Corp., from to . As of , FDA records show no recalls naming K964206.

Clearance record

Decision date
Received
(242 days to decision)
Product code
IYE Accelerator, Linear, Medical
Regulation
21 CFR 892.5050
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 IYE

Trailing 12 months
15 clearances under product code IYE in the twelve months to November 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code IYE, trailing twelve months
MonthClearances
December 20251
January 20264
February 20260
March 20261
April 20262
May 20261
June 20262
July 20260
August 20263
September 20261
October 20260
November 20260