← Back to catalogue

AccuLeaf Modification

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040553

by Direx Systems Corp.

Identifiers

510(k) Number
K040553 FDA 510(k)
FDA Product Code
IXI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5710 FDA 510(k)
Regulation Number
892.5710 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The AccuLeaf Modification is a Block, Beam-Shaping device used in Radiation Therapy. It is designed to precisely shape and collimate radiation beams to improve targeting accuracy during treatment, reducing exposure to surrounding healthy tissue.

This device is supplied as a reusable component and is intended for use in radiology settings. It is classified as a Class II medical device under 21 CFR 892.5710 and has received FDA 510(k) clearance with a Special review type. The modification was authorized under K-number K040553 and is intended for integration with existing radiation therapy systems.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MODIFICATION TO ACCULEAF (K040553) — FDA 510 (k) | Innolitics, PDF MODIFICATION TO ACCULEAF 510 (k) K040553 - FDA.report, PDF K040553 MODIFICATION TO ACCULEAF - 510kdatabase.net, Direx Acculeaf - allmed.wiki

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Direx Systems Corp.

Sources (1)

  • FDA 510(k) K040553 24 fields · synced Sep 19, 2026