510(k) · Cleared
Recalled · 2005Wise (II) Image Management 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 29, 1998 as substantially equivalent to K971451 (O Tech, Inc., 1997) after a 29-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Oct 29, 1998
- Review
- 29 days
- Class
- Class I
- Product code
- LMB
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922164 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK922164 Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993
- 2 generations backK963395 Imageserver 2000 Picture Archiving SystemSectra-Imtec AB · 1996
- 1 generation backK971451 Wise Image Management SystemO Tech, Inc. · 1997
- This deviceK983447 Wise (II) Image Management SystemSectra-Imtec AB · 1998
- Descendant · cites it directly · 0 of its ownK992426 Raypax Web Clinical SystemSamsung Sds Co., Ltd. · 1999
Most influential descendants
Showing 1 of 1 · See all- K992426Raypax Web Clinical SystemSamsung Sds Co., Ltd. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922164 | Raytel Digital Imaging Systems | Olicon Imaging Systems, Inc. | 1993 | — |
| −2 | K963395 | Imageserver 2000 Picture Archiving System | Sectra-Imtec AB | 1996 | — |
| −1 | K971451 | Wise Image Management System | O Tech, Inc. | 1997 | — |
| 0 (this device) | K983447 | Wise (II) Image Management System | Sectra-Imtec AB | 1998 | — |
| +1 | K992426 | Raypax Web Clinical System | Samsung Sds Co., Ltd. | 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 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 |
|---|---|---|---|
| * | K971451 | Wise Image Management SystemSummary page 1…tem Common Name: Digital Imaging System Classification Name: System, Digital Image Communication, Accessory Predicate Device: Applicant: Sectra Imtec AB 510(k) Number: K971451 Device: WISE Image Management System Device Description: WISE 1I is a system for managing digital radiological images. This incl… | 1997 |
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 |
|---|---|---|---|
| K992426 | Raypax Web Clinical System | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 16, 2005 | Not classified | Z-0695-05 | Other | Failure to update correctly when re-transmitting an image from the modality. |
| Jun 27, 2003 | Not classified | Z-1125-03 | Other | If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems. |
| Feb 13, 2002 | Not classified | Z-1223-03 | Other | Potential display of an incorrect body part description on patient images. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K992426 (Samsung Sds Co., Ltd., 1999) has gone furthest, with 0 descendants of its own.
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 Sectra WISE Image Management System device is intended for the management and displaying of x-ray images, other radiological objects, and information.
It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
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/K983447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983447: Wise (II) Image Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983447
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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