# K970964: Maestro Digital Image and Patient Record Storage System

- Pathway: 510(k) (Traditional)
- Applicant: International Imaging Electronics
- Decided: Jun 13, 1997 after 88 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
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
This device is intended to be used by all medical and dental personnel to store all patient medical or dental ‘records on CD, Digital Audio Tapes or any future digital archivable media. The Maestro product is capable of trahsmitting patient records or claims to third party administrators or insurance companies for processing of patient insurance claims. Maestro allows a user o use digital zocom-in features to enlarge an x-ray film/images, or any type of document for closer examination.

Source page: https://510kreport.com/device/K970964
Methodology: https://510kreport.com/methodology