Question 1

What types of medical devices does Ion Beam Applications S.A. manufacture?

Accepted Answer

Ion Beam Applications S.A. specializes in designing and manufacturing proton therapy systems, primarily the Proteus 235 series (including Proteus One, Proteus Plus, Proteus TK2, and Proteus Class). These systems are used for targeted cancer treatment by delivering precise radiation doses via proton beams, minimizing exposure to healthy tissue. The company also produces gantry beam lines and modifications for existing systems, as well as the I2C system, which supports the therapy infrastructure.

Question 2

Where is Ion Beam Applications S.A. based?

Accepted Answer

Ion Beam Applications S.A. is headquartered in the United States. The company’s location influences its regulatory compliance, particularly for devices marketed in the U.S., where its proton therapy systems are subject to FDA oversight.

Question 3

Which regulatory registries list Ion Beam Applications S.A.’s devices?

Accepted Answer

Ion Beam Applications S.A.’s proton therapy systems, including the Proteus 235 series and associated components, are listed in the FDA’s 510(k) registry. This registry tracks Class II medical devices that have undergone the FDA’s 510(k) clearance process, demonstrating compliance with applicable safety and performance standards before commercial distribution.

Question 4

How are Ion Beam Applications S.A.’s devices classified under medical device regulations?

Accepted Answer

The company’s proton therapy systems, such as the Proteus 235 series and gantry beam lines, are classified as Class II medical devices. This classification is determined by the FDA based on the level of risk associated with the device’s intended use. Class II devices require special controls in addition to general controls to ensure their safety and effectiveness, and they must undergo a 510(k) premarket notification process to demonstrate compliance.

Device	Model / Reference	Registries	Class	Status
I2C (IBA Image-Guided Therapy Console)	adaPTinsight	FDA UDI	Class II	Active
Proteus 235	Proteus ONE	FDA UDI	Class II	Active
I2C (IBA Image-Guided Therapy Console)	adaPTinsight	FDA UDI	Class II	Active
I2C (IBA Image-Guided Therapy Console)	adaPTinsight	FDA UDI	Class II	Active
I2C (IBA Image-Guided Therapy Console)	adaPTinsight	FDA UDI	Class II	Active
I2C (IBA Image-Guided Therapy Console)	adaPTinsight	FDA UDI	Class II	Active
I2C (IBA Image-Guided Therapy Console)	adaPTinsight	FDA UDI	Class II	Active
I2C (IBA Image-Guided Therapy Console)	adaPTinsight	FDA UDI	Class II	Active
Proteus 235	Proteus PLUS	FDA UDI	Class II	Active
Proteus 235	Proteus PLUS	FDA UDI	Class II	Active
Proteus 235	Proteus PLUS	FDA UDI	Class II	Active
I2C (IBA Image Guided Therapy Console)	adaPTinsight	FDA UDI	Class II	Active
I2C (IBA Image-Guided Therapy Console)	adaPTinsight	FDA UDI	Class II	Active
I2C (IBA Image-Guided Therapy Console)	adaPTinsight	FDA UDI	Class II	Active
Proteus 235	Proteus ONE	FDA UDI	Class II	Active
IBA Proton Therapy System – Proteus 235	Proteus PLUS/Proteus ONE	FDA UDI	Class II	Active
I2C (IBA Image-Guided Therapy Console)	adaPTinsight	FDA UDI	Class II	Active
Iba Proton Therapy System, Model Proteus 235	K100766	FDA 510(k)	Class II	Active
Proton Therapy System	K983024	FDA 510(k)	Class II	Active
Gantry Beam Line	K132919	FDA 510(k)	Class II	Active
Iba Proton Therapy System - Proteus 235	K083058	FDA 510(k)	Class II	Active
Iba Proton Therapy System- Proteus 235	K082416	FDA 510(k)	Class II	Active
Iba Proton Therapy System, Proteus 235	K092796	FDA 510(k)	Class II	Active
Proteus 235 Proton Therapy System	K091629	FDA 510(k)	Class II	Active
Iba Proton Therapy System - Proteus 235	K060695	FDA 510(k)	Class II	Active
Modification To Iba Proton Therapy System-Proteus 235	K101508	FDA 510(k)	Class II	Active
I2c	K132847	FDA 510(k)	Class II	Active
Iba Proton Therapy System - Proteus 235	K061913	FDA 510(k)	Class II	Active
Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)	K152224	FDA 510(k)	Class II	Active
IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)	K163500	FDA 510(k)	Class II	Active
Iba Proton Therapy System-Proteus 235	K053641	FDA 510(k)	Class II	Active

Ion Beam Applications S.A.

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