Question 1

What types of medical devices does Oncospace, Inc. manufacture?

Accepted Answer

Oncospace, Inc. specializes in radiation therapy software, specifically tools that assist in planning and delivering precise cancer treatments. Their products are designed to improve accuracy in radiation therapy, ensuring safer and more effective patient care.

Question 2

Where is Oncospace, Inc. based, and does that affect its regulatory standing?

Accepted Answer

Oncospace, Inc. is based in the United States. Since the company’s devices are authorised through FDA pathways, its location aligns with U.S. regulatory requirements. However, regulatory status depends on individual device authorisations, not the company itself.

Question 3

Which regulatory registries or databases list Oncospace’s devices?

Accepted Answer

Oncospace’s devices are registered in the FDA’s 510(k) and UDI (Unique Device Identification) databases. These registries track authorised medical devices under U.S. regulations, ensuring compliance and traceability.

Question 4

How are Oncospace’s devices classified by regulatory authorities?

Accepted Answer

Oncospace’s products fall under FDA Class II device classification. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.

Device	Model / Reference	Registries	Class	Status
Oncospace	System	FDA UDI	Class II	Active
Oncospace	K202284	FDA 510(k)	Class II	Active
Oncospace	K222803	FDA 510(k)	Class II	Active
Oncospace	K242748	FDA 510(k)	Class II	Active

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