510(k) · Cleared
ClearedMiltra Imaging Inc., Image Vault
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitra Imaging, Inc. · LMD System, Digital Image Communications, Radiological
Cleared on Jan 20, 1998 after an 81-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jan 20, 1998
- Review
- 81 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK974102 Miltra Imaging Inc., Image VaultMitra Imaging, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK984215 Welch Allyn Front-Line DocWelch Allyn, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K984215Welch Allyn Front-Line DocWelch Allyn, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974102 | Miltra Imaging Inc., Image Vault | Mitra Imaging, Inc. | 1998 | — |
| +1 | K984215 | Welch Allyn Front-Line Doc | Welch Allyn, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LMD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Kodak Cardiac Archive Station CAS 6000 Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984215 | Welch Allyn Front-Line Doc | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K984215 (Welch Allyn, Inc., 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LMD devicesLMD System, Digital Image Communications, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMD
FDA has decided no LMD device since 2007.
Median 510(k) review, days · LMD
Too few LMD 510(k)s in any year since 2007 to give a median.
Recalls per year · LMD
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMD
16in 2025
MAUDE reports naming product code LMD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 1 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 1 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 2 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (153 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974102 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974102: Miltra Imaging Inc., Image Vault.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974102
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026