3D Bolus, Inc.
CA Last updated 22 Oct 2026
Is this your brand? Sign in to claim this brand
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
3D Bolus Software Ref K180289
What 3D Bolus, Inc. makes
3D Bolus, Inc. develops 3D Bolus Software, a digital tool designed for radiation therapy planning to model and visualize tumor and organ dose distributions in three dimensions, improving treatment precision.
The company’s portfolio is regulated under FDA’s Class II device classification and requires 510(k) clearance. The software is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does 3D Bolus, Inc. manufacture or develop?
3D Bolus, Inc. specializes in developing 3D Bolus Software, a digital tool used in radiation therapy planning. This software helps model and visualize tumor and organ dose distributions in three dimensions, which enhances the precision of treatment planning for patients.
Where is 3D Bolus, Inc. based, and how does that affect its regulatory oversight?
3D Bolus, Inc. is based in the United States, where its devices fall under the jurisdiction of the FDA (U.S. Food and Drug Administration). Since the company’s products are regulated as Class II devices, they require 510(k) clearance before commercial distribution, demonstrating compliance with U.S. medical device regulations.
Are 3D Bolus, Inc.’s devices listed in any regulatory registries, and why does this matter?
Yes, 3D Bolus Software is listed in the FDA’s 510(k) database, which confirms its regulatory clearance status. This registry is publicly accessible and serves as proof that the device has undergone the required review process to ensure safety and effectiveness before entering the market.
How are 3D Bolus, Inc.’s devices classified by regulatory authorities, and what does that classification mean?
3D Bolus, Inc.’s devices are classified as Class II by the FDA. This classification indicates that while the products are not considered high-risk (unlike Class III), they still require pre-market clearance (such as a 510(k)) to ensure they meet specific performance standards and do not pose unreasonable risks to patients.
Information
- Country
- CA