510(k) · Cleared

Cleared

Aidp (Accuimage Image Display Processor)

K961023510(k) TraditionalCleared Sep 9, 1996179-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

Accuimage, Inc. · LMD System, Digital Image Communications, Radiological

Cleared on Sep 9, 1996 as substantially equivalent to K945188 (Cemax, Inc., 1995) after a 179-day review. Its family tree reaches back 1 generation to 1995. 1 of the 284 devices in its family, counting itself, has a Class I recall. 282 later devices descend from it.

Decided: Sep 9, 1996
Review: 179 days
Class: Class I
Product code: LMD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K945188 (1995). 282 later devices descend from it, 10 citing it directly. 1 of the 284 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
This deviceK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
Descendant · cites it directly · 208 of its ownK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
Descendant · 2 generations on · 207 of its ownK012086 Aquariusnet ServerTerarecon,Inc. · 2001
Descendant · 3 generations on · 134 of its ownK061214 Aquariusaps ServerTerarecon,Inc. · 2006
Descendant · 4 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
Descendant · 5 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013

Showing 5 of 282 descendants. See all descendants

Descendants cleared per year

1998high 23 (2024) · low 1 (2001)2026

Class I recalls in this family

K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025

Most influential descendants

Showing 5 of 282 · See all

K994329Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000 · cites it directly208descendants
K012086Aquariusnet ServerTerarecon,Inc. · 2001 · 2 generations on207descendants
K061214Aquariusaps ServerTerarecon,Inc. · 2006 · 3 generations on134descendants
K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 4 generations on99descendants
K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 5 generations on63descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945188	Cemax Vipstation and/or Software	Cemax, Inc.	1995	—
0 (this device)	K961023	Aidp (Accuimage Image Display Processor)	Accuimage, Inc.	1996	—
+1	K994329	Iivs Integrated Image Viewing Station	Terarecon,Inc.	2000	—
+2	K012086	Aquariusnet Server	Terarecon,Inc.	2001	—
+3	K061214	Aquariusaps Server	Terarecon,Inc.	2006	—
+4	K112020	Syngo.CT Vascular Analysis	Siemens Medi Cal Solutions, Inc.	2011	—
+5	K123920	Syngo.Via	Siemens AG Medical Solutions	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	6	0
1999	2	0
2000	2	0
2001	1	0
2002	3	0
2003	3	0
2004	5	0
2005	3	0
2006	8	0
2007	5	0
2008	11	0
2009	6	0
2010	8	0
2011	10	0
2012	10	0
2013	10	0
2014	6	0
2015	10	0
2016	6	0
2017	8	0
2018	14	0
2019	12	0
2020	22	0
2021	13	0
2022	15	0
2023	18	0
2024	23	0
2025	23	1
2026	19	0

FIG. 1 — Lineage of K961023, 1995–2026Source: 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.

1 device in this family has a Class I recall. 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? (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	Applicant	Decided	Recalls
*	K945188	Cemax Vipstation and/or Software Summary page 1 …ng Common/Usual Name: Image Processing Workstation Proprietary Name: Acculmage, Inc. Iimage Display Processor Substantial Equivalence Cemax VIPStation and/or Software K945188, 2-Aug.-95 Device Description and Intended Use The intended use of this software package is to render 3-dimensional images from…	Cemax, Inc.	1995	—

What descends from it? (282)

See all 282

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

Number	Device	Applicant	Decided	Descendants
K994329	Iivs Integrated Image Viewing Station	Terarecon,Inc.	2000	208
K972701	Barco MWD 321 Medical Workstation Display	Barco NV Display Systems	1998	38
K980541	Barco MGD 521 5 Megapixel Diagnostic Display	Barco NV Display Systems	1998	33
K031779	Cadstream	Confirma, Inc.	2003	19
K041286	Dynacad V1.0	Mri Devices Corp.	2004	17
K982535	Insight Diagnostic Imaging Workstation	Neo Imagery Technologies, Inc.	1998	9
K990241	Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope…	Accuimage Diagnostics Corp.	1999	8
K992354	SNT Image Analysis System	Surgical Navigation Technologies, Inc.	1999	2
K994054	Issa Pharos	Vams Tec, D.O.O.	2000	0
K983392	Data Ray Corporation DR11021 Medical Imaging Monitor	Data Ray	1998	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K994329 (Terarecon,Inc., 2000) has gone furthest, with 208 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

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 intended use of this software package is to render 3-dimensional images from a series of Computer Tomography cross sectional 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/K961023 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961023: Aidp (Accuimage Image Display Processor).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961023

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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