510(k) · Cleared
ClearedImageserver 2000 Picture Archiving System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sectra-Imtec AB · LMB Device, Digital Image Storage, Radiological
Cleared on Oct 25, 1996 as substantially equivalent to K922164 (Olicon Imaging Systems, Inc., 1993) after a 58-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Oct 25, 1996
- Review
- 58 days
- Class
- Class I
- Product code
- LMB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922164 (1993). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK922164 Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993
- This deviceK963395 Imageserver 2000 Picture Archiving SystemSectra-Imtec AB · 1996
- Descendant · cites it directly · 2 of its ownK971451 Wise Image Management SystemO Tech, Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK983447 Wise (II) Image Management SystemSectra-Imtec AB · 1998 · Recalled
- Descendant · 3 generations on · 0 of its ownK992426 Raypax Web Clinical SystemSamsung Sds Co., Ltd. · 1999
- Descendant · cites it directly · 0 of its ownK980241 Netco Medical Data Transportation Service SoftwareNetco Communications Corp. · 1998
Most influential descendants
Showing 4 of 4 · See all- K971451Wise Image Management SystemO Tech, Inc. · 1997 · cites it directly2descendants
- K983447Wise (II) Image Management SystemSectra-Imtec AB · 1998 · 2 generations on1descendant
- K992426Raypax Web Clinical SystemSamsung Sds Co., Ltd. · 1999 · 3 generations on0descendants
- K980241Netco Medical Data Transportation Service SoftwareNetco Communications Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922164 | Raytel Digital Imaging Systems | Olicon Imaging Systems, Inc. | 1993 | — |
| 0 (this device) | K963395 | Imageserver 2000 Picture Archiving System | Sectra-Imtec AB | 1996 | — |
| +1 | K971451 | Wise Image Management System | O Tech, Inc. | 1997 | — |
| +2 | K983447 | Wise (II) Image Management System | Sectra-Imtec AB | 1998 | 3 |
| +3 | K992426 | Raypax Web Clinical System | Samsung Sds Co., Ltd. | 1999 | — |
| +1 | K980241 | Netco Medical Data Transportation Service Software | Netco Communications Corp. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 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 LMB? 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 |
|---|---|---|---|
| * | K922164 | Raytel Digital Imaging SystemsSummary page 1…Notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence to Olicon Imaging Systms, Inc. (K922164). This information and data is summarized as follows: 1. The ImageServer system is subject to and in compliance with the Federal… | 1993 |
What descends from it? (4)
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?
How does its category compare?
All LMB devicesLMB Device, Digital Image Storage, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMB
FDA has decided no LMB device since 2007.
Median 510(k) review, days · LMB
Too few LMB 510(k)s in any year since 2007 to give a median.
Recalls per year · LMB
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMB
7in 2025
MAUDE reports naming product code LMB, 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 | — | 0 | 1 |
| 2008 | 0 | — | 1 | 3 |
| 2009 | 0 | — | 5 | 3 |
| 2010 | 0 | — | 0 | 16 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 1 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ImageServer 2000 System will be used for digitally store images for archival together with informaton about the images.
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/K963395 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963395: Imageserver 2000 Picture Archiving System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963395
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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