510(k) · Cleared
ClearedMedisurf
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Regulatory Consultants · LMD System, Digital Image Communications, Radiological
Cleared on Jul 3, 1997 as substantially equivalent to K954678 (Algotec Systems, Ltd., 1996) after an 84-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it.
- Decided
- Jul 3, 1997
- Review
- 84 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954678 (1996). 6 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- This deviceK971347 MedisurfInternational Regulatory Consultants · 1997
- Descendant · cites it directly · 1 of its ownK982769 Mitra Imaging Inc. ExhibitMitra Imaging, Inc. · 1998 · Recalled
- Descendant · cites it directly · 1 of its ownK981053 Kodak Digital Sciences (KDS) Image ViewEastman Kodak Company · 1998
- Descendant · cites it directly · 0 of its ownK031473 Rational Imaging PacsIntuitive Imaging Informatics, LLC · 2003
- Descendant · 2 generations on · 0 of its ownK992698 Stentor, PageviewStentor, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK984405 Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp. · 1999
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K982769Mitra Imaging Inc. ExhibitMitra Imaging, Inc. · 1998 · cites it directly1descendant
- K981053Kodak Digital Sciences (KDS) Image ViewEastman Kodak Company · 1998 · cites it directly1descendant
- K031473Rational Imaging PacsIntuitive Imaging Informatics, LLC · 2003 · cites it directly0descendants
- K992698Stentor, PageviewStentor, Inc. · 1999 · 2 generations on0descendants
- K984405Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| 0 (this device) | K971347 | Medisurf | International Regulatory Consultants | 1997 | — |
| +1 | K982769 | Mitra Imaging Inc. Exhibit | Mitra Imaging, Inc. | 1998 | 1 |
| +1 | K981053 | Kodak Digital Sciences (KDS) Image View | Eastman Kodak Company | 1998 | — |
| +1 | K031473 | Rational Imaging Pacs | Intuitive Imaging Informatics, LLC | 2003 | — |
| +2 | K992698 | Stentor, Pageview | Stentor, Inc. | 1999 | — |
| +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 |
|---|---|---|
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K954678 | Pro VisionSummary page 1…000 Tel: +972-9-748-2442 Fax: +972-9-748-2411 Name of the Device : MediSurf. Predicate Device : ProVision Diagnostic Workstation manufactured by Algotec Systems Ltd. (K954678). Description of the Device : The MediSurf server is an access engine to health- care information. MediSurf provides its end-use… | 1996 |
What descends from it? (6)
5 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 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?
MediSurf is intended to facilitate access to clinical images and information in distributed locations. Along with image processing capabilities,
MediSurf can be used by radiologists for on-call teleradiology over “intranets”, Internet, direct or dial-up lines, and for providing second opinion services. It can also be used by physicians for enhanced interpretation of cases through the inclusion of images in imaging related reports and in patient records in general. Similarly it can be used by healthcare organization staff for facilitated access to clinical images throughout the healthcare organization.
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/K971347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971347: Medisurf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971347
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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