120 Leaf Multileaf Collimator
by Mitsubishi Electronics America, Inc.
510(k) K973963
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973963 | Date14 Jan 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYE
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The 120 Leaf Multileaf Collimator is a medical device classified as an accelerator accessory, specifically designed for beam shaping in external beam radiotherapy. It functions as a precision collimator to modulate radiation fields during treatment, replacing traditional custom-fabricated blocks by dynamically adjusting leaf positions for targeted dose delivery.
This device is supplied as a reusable accessory for Mitsubishi EXL series linear accelerators and includes a collimator assembly, Local Control Equipment (LCE) in the treatment room, and a Multi-Leaf Controller Unit (MLCU). It is intended for use in radiology settings and has received FDA 510(k) clearance under the Traditional pathway, with a classification as a Class II device (regulation number 892.5050). No sterility or single-use specifications are indicated in the data.
Other devices from Mitsubishi Electronics America, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the 120 Leaf Multileaf Collimator in radiotherapy treatment?
The 120 Leaf Multileaf Collimator is designed to shape and modulate radiation fields during external beam radiotherapy. It dynamically adjusts leaf positions to precisely target dose delivery, replacing traditional custom-fabricated blocks for improved accuracy and flexibility in treatment planning.
Is this device intended for single-use or reusable applications, and what components are included?
The 120 Leaf Multileaf Collimator is a reusable accessory. It includes a collimator assembly, Local Control Equipment (LCE) in the treatment room, and a Multi-Leaf Controller Unit (MLCU), all of which are intended for use with Mitsubishi EXL series linear accelerators.
How is the regulatory status of this device determined, and what pathway was used for FDA clearance?
The device received FDA 510(k) clearance under the Traditional pathway and is classified as a Class II medical device under regulation number 892.5050. The clearance was based on a determination of substantial equivalence to a predicate device, as indicated by the 'Substantially Equivalent' decision description.
Which linear accelerator models is this collimator compatible with, and where is it primarily used?
The 120 Leaf Multileaf Collimator is specifically designed for use with Mitsubishi EXL series linear accelerators. It is intended for radiology settings, where precise radiation field shaping is required during external beam radiotherapy treatments.
Are there any specific storage requirements mentioned for this device?
The provided data does not specify any particular storage requirements for the 120 Leaf Multileaf Collimator. However, as a reusable medical device, it should be stored in a clean, dry environment to maintain its functionality and hygiene standards.