Autimo 2.5-D and Autimo 3-D
by C.L. Mcintosh & Assoc., Inc. 510(k)
Active
510(k) K972016
Overview
The device is a Block, Beam-Shaping, Radiation Therapy system intended for use in radiotherapy. It is designed for the fabrication and positioning of irregular shielding blocks, compensators, and dose modifiers.
It is a Class 2 medical device with product code IXI, cleared via the FDA 510(k) pathway under regulation number 892.5710. The device is manufactured by C.L. Mcintosh & Assoc., Inc. and was granted substantial equivalence on December 4, 1997, following a traditional 510(k) review.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972016 | Date4 Dec 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IXI
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5710
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from C.L. Mcintosh & Assoc., Inc.
Questions
What is the AUTIMO 2.5-D and 3-D device used for?
The AUTIMO 2.5-D and 3-D is intended for use in radiotherapy to fabricate and position irregular shielding blocks, compensators, and dose modifiers, which are used to shape radiation beams and protect healthy tissue during treatment.
How is the AUTIMO 2.5-D and 3-D supplied or configured for use?
The device is a beam-shaping system designed for the fabrication and positioning of custom radiotherapy accessories; it is not a disposable or single-use item but a reusable system used to create patient-specific shielding and dose-modifying components.
Is the AUTIMO 2.5-D and 3-D a single-use or reusable device?
The AUTIMO 2.5-D and 3-D is a reusable system intended for multiple uses in the fabrication of radiotherapy accessories such as shielding blocks and compensators; it is not designed as a single-use disposable device.
What regulatory pathway was used for the AUTIMO 2.5-D and 3-D?
The AUTIMO 2.5-D and 3-D received FDA 510(k) clearance via a traditional review process, demonstrating substantial equivalence to a predicate device, and was granted clearance on December 4, 1997.
What class of medical device is the AUTIMO 2.5-D and 3-D?
The AUTIMO 2.5-D and 3-D is classified as a Class 2 medical device, as indicated by its product code IXI and regulation number 892.5710 under FDA regulations.