Mentor Isoloader Automatic Needle Loading System and Physics Workstation for Brachytherapy

by Mentor Corp. United States 510(k)

510(k) K011493 Product code KPT

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK011493	Date1 Oct 2002Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 10 Oct 2026)

Specification

510(k) · synced 10 Oct 2026

510(k) Number: K011493
FDA Product Code: KPT

Device Class: Class II
Regulation: 21 CFR Part 892.1360
Advisory Committee: Radiology
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K011493 24 fields · synced 10 Oct 2026