510(k) · Cleared

Cleared

Amicas Web/Intranet Image Server

K970064510(k) TraditionalCleared Mar 17, 199769-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

Autocyt Group, Inc. · LMD System, Digital Image Communications, Radiological

Cleared on Mar 17, 1997 as substantially equivalent to K924178 (Evergreen Technologies, Inc., 1993) and 1 other predicate after a 69-day review. Its family tree reaches back 1 generation to 1993. 40 later devices descend from it.

Decided: Mar 17, 1997
Review: 69 days
Class: Class I
Product code: LMD
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K924178 (1993). 2 ancestors in all. 40 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 1 generation backK924178 Medvision (TM) Imaging SoftwareEvergreen Technologies, Inc. · 1993
This deviceK970064 Amicas Web/Intranet Image ServerAutocyt Group, Inc. · 1997
Descendant · cites it directly · 18 of its ownK012097 VortexUltravisual Medical Systems · 2001
Descendant · 2 generations on · 14 of its ownK061421 Erad PacsErad, Inc. · 2006
Descendant · cites it directly · 13 of its ownK973131 Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Siemens Medical Solutions USA, Inc. · 1997
Descendant · 3 generations on · 7 of its ownK120995 Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc. · 2012
Descendant · 2 generations on · 6 of its ownK033831 Sienet CosmosSiemens AG Medical Solutions · 2003 · Recalled

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

1997high 4 (2005) · low 0 (2008)2026

Most influential descendants

Showing 5 of 40 · See all

K012097VortexUltravisual Medical Systems · 2001 · cites it directly18descendants
K061421Erad PacsErad, Inc. · 2006 · 2 generations on14descendants
K973131Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Siemens Medical Solutions USA, Inc. · 1997 · cites it directly13descendants
K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc. · 2012 · 3 generations on7descendants
K033831Sienet CosmosSiemens AG Medical Solutions · 2003 · 2 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924178	Medvision (TM) Imaging Software	Evergreen Technologies, Inc.	1993	—
0 (this device)	K970064	Amicas Web/Intranet Image Server	Autocyt Group, Inc.	1997	—
+1	K012097	Vortex	Ultravisual Medical Systems	2001	—
+2	K061421	Erad Pacs	Erad, Inc.	2006	—
+1	K973131	Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)	Siemens Medical Solutions USA, Inc.	1997	—
+3	K120995	Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product	Erad, Inc.	2012	—
+2	K033831	Sienet Cosmos	Siemens AG Medical Solutions	2003	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	3	0
2000	1	0
2001	1	0
2002	1	0
2003	3	0
2004	2	0
2005	4	0
2006	2	0
2007	2	0
2010	1	0
2011	1	0
2012	1	0
2013	2	0
2014	2	0
2015	1	0
2016	2	0
2017	1	0
2018	1	0
2020	3	0
2023	2	0
2024	2	0

FIG. 1 — Lineage of K970064, 1993–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K924178	Medvision (TM) Imaging Software Summary page 3 …. 10. Comparison with Equivalent Devices AMICAS has Indications for Use similar to other medical image viewers such as Evergreen Technologies MedVision [ 510(k) Number K924178 ] or the RSTAR Image Management System [ 510(k) Number K943994 ]. AMICAS also shares with these devices a Target Population that…	Evergreen Technologies, Inc.	1993	—
*	K943994	Pacs Equipment Summary page 3 …ns for Use similar to other medical image viewers such as Evergreen Technologies MedVision [ 510(k) Number K924178 ] or the RSTAR Image Management System [ 510(k) Number K943994 ]. AMICAS also shares with these devices a Target Population that is competent health professionals. Also equivalent to these dev…	Rstar Image Management System	1995	—

Also cleared against K924178: 1 other device →

What descends from it? (40)

See all 40

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

Number	Device	Applicant	Decided	Descendants
K012097	Vortex	Ultravisual Medical Systems	2001	18
K973131	Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)	Siemens Medical Solutions USA, Inc.	1997	13
K994228	Remoteimage System	Etrauma.Com Corp.	2000	1
K983815	Pacscache	Dome Imaging Systems, Inc.	1999	1
K051745	Echosystem	Medstrat, Inc.	2005	0
K024159	Strykerware System	Stryker Endoscopy	2003	0
K984405	Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000	Intracom Corp.	1999	0
K980243	Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis)	Parameter Developments, Inc.	1998	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K012097 (Ultravisual Medical Systems, 2001) has gone furthest, with 18 descendants of its own.
1 other device also cites its predicate K924178.

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

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

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

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	1
2008	—	1	2
2009	—	1	3
2010	—	0	9
2011	—	0	1
2012	—	1	2
2013	—	0	4
2014	—	0	12
2015	—	1	9
2016	—	0	3
2017	—	0	2
2018	—	0	4
2019	—	0	2
2020	—	2	2
2021	—	0	2
2022	—	0	6
2023	—	0	7
2024	—	0	8
2025	—	0	16
2026	—	0	—

What is it indicated for?

The software is to be used for the remote viewing of files generated by a medical scanning device and acquired according to the dominant industry-standard communications format (DICOM 3.0).

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/K970064 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970064: Amicas Web/Intranet Image Server.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970064

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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