# K972016: Autimo 2.5-D and Autimo 3-D

- Pathway: 510(k) (Traditional)
- Applicant: C.L. Mcintosh & Assoc., Inc.
- Decided: Dec 4, 1997 after 188 days
- Product code: IXI (Block, Beam-Shaping, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K844180 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844180: The MCP-70-SE System, Ellis Pharmaceutical Consulting, Inc. (1985) Summary page 1.

## Indications for use
The 2.5 D and 3-D AUTIMO systems are intended for the fabrication and positioning in radiotherapy of irregular shielding blocks, compensators, and dose modifiers.

Source page: https://510kreport.com/device/K972016
Methodology: https://510kreport.com/methodology