# K150976: Collage

- Pathway: 510(k) (Traditional)
- Applicant: Anatomage, Inc.
- Decided: Jun 4, 2015 after 52 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K942120 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101342: Osirix MD, Pixmeo Sarl (2010) Summary page 5.

## Indications for use
Collage is a software application intended for viewing of 3D medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound as well as 2D patient images, such as patient photographs, intraoral photographs, and dental x-rays. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. It is intended for use by doctors, clinicians, and other qualified individuals utilizing standard PC hardware. This device is not indicated for mammography use.

Source page: https://510kreport.com/device/K150976
Methodology: https://510kreport.com/methodology