AIO Solution 3.0 Linear Accelerator

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K202068Ref 38246Model 0030

by Orfit Industries NV

Identity

Trade Name: The AIO Solution EUDAMED
Device Name: The AIO Solution® (All-in-One Patient Positioning Solution) EUDAMED
Model / Reference: 0030 EUDAMED
38246 EUDAMED

Identifiers

Primary DI / UDI-DI: 54011720037055 EUDAMED
Basic UDI-DI: 5420028700304T EUDAMED
Direct Marketing DI: 54011720037055 EUDAMED
510(k) Number: K202068 FDA 510(k)
FDA Product Code: IYE FDA 510(k)
EMDN Code: Z11010180 LINEAR ACCELERATORS - HARDWARE ACCESSORIES EUDAMED

Classification

Device Class: Class I EUDAMED
Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 892.5050 FDA 510(k)
Regulation Number: 892.5050 FDA 510(k)
Market of Registration: Belgium EUDAMED
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

The AIO Solution 3.0 is a linear accelerator, a medical device used for high-energy radiation therapy in oncology. It delivers precise, targeted radiation to treat malignant tumors by accelerating electrons to high velocities and directing them at tumor sites with controlled dose delivery.

This device is designed for use in radiation oncology departments within hospitals or specialized cancer treatment centers. Supplied as a reusable, non-sterile system, it requires proper maintenance and calibration to ensure accurate radiation output. The AIO Solution 3.0 complies with FDA 510(k) clearance under the Traditional pathway and is classified as a Class II device under the Medical Device Regulation (MDR). It is intended for MRI-unsafe environments due to its electromagnetic properties and must be operated by trained radiation therapists.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K202068	Class II	Active

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Manufacturer

Manufacturer: Orfit Industries NV

Sources (2)

FDA 510(k) K202068 24 fields · synced Oct 6, 2026
EUDAMED 32051fb3-7722-4139-8c9f-7ff033c23b0b 61 fields · synced Jul 12, 2026