# K974102: Miltra Imaging Inc., Image Vault

- Pathway: 510(k) (Traditional)
- Applicant: Mitra Imaging, Inc.
- Decided: Jan 20, 1998 after 81 days
- Product code: LMD (System, Digital Image Communications, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kodak Cardiac Archive Station CAS 6000: named in the summary without a submission number

## Most influential descendants
- K984215: Welch Allyn Front-Line Doc (1999), 0 descendants of its own

## Indications for use
Vault is intended to act as a long term storage device (archive) for medical images. Vault is a networked device that acts as a DICOM Storage Service Class Provider (SCP): Images can be sent to it via the DICOM protocol, from modalities or other devices that are sources of medical images. Images can subsequently be queried and retrieved via the DICOM protocol to imaging workstations and other processing devices. Internally, Vault is optimized to provide secure storage for a very large number of images, and to provide rapid retrieval on demand. To that end, Vault includes high capacity storage media, and has implemented hierarchical storage management software to manage cache storage effectively. Users: The Vault will be located in a hospital department. The expected users are as follows: Service personnel for installation, configuration and support. System administrator within the department, who in many cases will be chief technologist or other designated clinical staff.

Source page: https://510kreport.com/device/K974102
Methodology: https://510kreport.com/methodology