510(k) · Cleared
ClearedImageaccess System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storcomm, Inc. · LMD System, Digital Image Communications, Radiological
Cleared on Jan 2, 1998 as substantially equivalent to K931454 (Image Premastering Services, Inc., 1993) after an 88-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Jan 2, 1998
- Review
- 88 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931454 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931454 Imageaccess SystemImage Premastering Services, Inc. · 1993
- This deviceK973805 Imageaccess SystemStorcomm, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK091631 Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK984405 Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp. · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931454 | Imageaccess System | Image Premastering Services, Inc. | 1993 | — |
| 0 (this device) | K973805 | Imageaccess System | Storcomm, Inc. | 1998 | — |
| +1 | K091631 | Accessnet, Accessmed, Accessrad, Medview | Aspyra, Inc. | 2010 | — |
| +1 | K984405 | Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 | Intracom Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K931454 | Imageaccess SystemSummary page 1…s the subject of this 510(k), ImageACCESS®, is substantially equivalent to the same device before the current modifications which was authorized for marketing via 510(k) K931454, decision date 12/14/93. Device Description: The Image ACCESS® system is a complete clinical image management system providing… | 1993 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K091631 (Aspyra, Inc., 2010) 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?
The intended use of the device is to allow storage and retrieval of medical images for
purposes of assisting in the diagnosis and/or treatment of diseases.
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/K973805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973805: Imageaccess System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973805
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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