510(k) Report

510(k) · Cleared

Cleared

Medvision (TM) Imaging Software

K924178510(k) TraditionalCleared Feb 2, 1993167-day reviewClass I21 CFR 892.2020

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Evergreen Technologies, Inc. · LMD System, Digital Image Communications, Radiological

Cleared on Feb 2, 1993 after a 167-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 42 later devices descend from it.

Decided
Feb 2, 1993
Review
167 days
Class
Class I
Product code
LMD
Recalls
None
Predicates
0

42 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 3 descendants cleared2003: 3 descendants cleared1998: 1 descendant cleared2005: 4 descendants cleared2000: 1 descendant cleared1999: 3 descendants cleared2001: 1 descendant cleared2004: 2 descendants cleared2006: 2 descendants cleared2002: 1 descendant cleared2010: 1 descendant cleared2013: 2 descendants cleared2011: 1 descendant cleared2014: 2 descendants cleared2012: 1 descendant cleared2007: 2 descendants cleared2016: 2 descendants cleared2017: 1 descendant cleared2024: 2 descendants cleared2015: 1 descendant cleared2018: 1 descendant cleared2020: 3 descendants cleared2023: 2 descendants cleared1990200020102020
  1. This deviceK924178 Medvision (TM) Imaging SoftwareEvergreen Technologies, Inc. · 1993
  2. Descendant · cites it directly · 40 of its ownK970064 Amicas Web/Intranet Image ServerAutocyt Group, Inc. · 1997
  3. Descendant · 2 generations on · 18 of its ownK012097 VortexUltravisual Medical Systems · 2001
  4. Descendant · 3 generations on · 14 of its ownK061421 Erad PacsErad, Inc. · 2006
  5. Descendant · 2 generations on · 13 of its ownK973131 Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Siemens Medical Solutions USA, Inc. · 1997
  6. Descendant · 4 generations on · 7 of its ownK120995 Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc. · 2012

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

1997: 31998: 11999: 32000: 12001: 12002: 12003: 32004: 22005: 42006: 22007: 22010: 12011: 12012: 12013: 22014: 22015: 12016: 22017: 12018: 12020: 32023: 22024: 2
1997high 4 (2005) · low 0 (2008)2026

Most influential descendants

Showing 5 of 42 · See all
  • K970064Amicas Web/Intranet Image ServerAutocyt Group, Inc. · 1997 · cites it directly40descendants
  • K012097VortexUltravisual Medical Systems · 2001 · 2 generations on18descendants
  • K061421Erad PacsErad, Inc. · 2006 · 3 generations on14descendants
  • K973131Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Siemens Medical Solutions USA, Inc. · 1997 · 2 generations on13descendants
  • K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc. · 2012 · 4 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924178Medvision (TM) Imaging SoftwareEvergreen Technologies, Inc.1993—
+1K970064Amicas Web/Intranet Image ServerAutocyt Group, Inc.1997—
+2K012097VortexUltravisual Medical Systems2001—
+3K061421Erad PacsErad, Inc.2006—
+2K973131Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Siemens Medical Solutions USA, Inc.1997—
+4K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199730
199810
199930
200010
200110
200210
200330
200420
200540
200620
200720
201010
201110
201210
201320
201420
201510
201620
201710
201810
202030
202320
202420
FIG. 1 — Lineage of K924178, 1993–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (42)

See all 42

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K970064Amicas Web/Intranet Image ServerAutocyt Group, Inc.199740
K973653Seemor - Display & Processing Program Executing on Personal Computer SystemAreeda Assoc., Ltd.19970

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, K970064 (Autocyt Group, Inc., 1997) has gone furthest, with 40 descendants of its own.

How does its category compare?

All LMD devices

LMD 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

2007: 22008: 12009: 12012: 12015: 12020: 2
2007high 2 (2007) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LMD

16in 2025

2007: 12008: 22009: 32010: 92011: 12012: 22013: 42014: 122015: 92016: 32017: 22018: 42019: 22020: 22021: 22022: 62023: 72024: 82025: 16
2007high 16 (2025) · low 1 (2007)2025

MAUDE reports naming product code LMD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—21
20080—12
20090—13
20100—09
20110—01
20120—12
20130—04
20140—012
20150—19
20160—03
20170—02
20180—04
20190—02
20200—22
20210—02
20220—06
20230—07
20240—08
20250—016
20260—0—

More from Evergreen Technologies, Inc.

7 FDA decisions under this applicant name. See the company

  • K942861Medvision Enviroment/Medvision 2.0Evergreen Technologies, Inc. · 1994
  • K942860Visionlink Dicom ModuleEvergreen Technologies, Inc. · 1994
  • K935103Visionlink Acr-Nema Conversion UtilitiesEvergreen Technologies, Inc. · 1994
  • K933372Visionlink Interfile Conversion SoftwareEvergreen Technologies, Inc. · 1993
  • K933209VisiontoolEvergreen Technologies, Inc. · 1993

Recent decisions in LMD

The LMD category page

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  • K992698Stentor, PageviewStentor, Inc. · 1999
  • K992426Raypax Web Clinical SystemSamsung Sds Co., Ltd. · 1999
  • K992352ITR2000: Internet Teleradiology, Model Release 1.0Inteleradiology, Inc. · 1999
  • K991537Samsung Raypax SystemSamsung Sds Co., Ltd. · 1999

https://510kreport.com/device/K924178 · printed Nov 5, 2026

Cite this page

510(k) Report. “K924178: Medvision (TM) Imaging Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K924178

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026