# K032022: Digital Imager

- Pathway: 510(k) (Traditional)
- Applicant: Pyramid Medical, Inc.
- Decided: Sep 2, 2003 after 64 days
- Product code: LMA (Digitizer, Image, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Digital Imager software is used to acquire and store image or patient data. This data can then be transmitted, stored and viewed over a computer network or off-site using an internet connection. Typical users of this system are trained professionals, including but not limited to physicians, technicians and nurses.

Source page: https://510kreport.com/device/K032022
Methodology: https://510kreport.com/methodology