510(k) · Cleared

Cleared

Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software

K973959510(k) TraditionalCleared Dec 22, 199767-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

Olicon Imaging Systems, Inc. · LMD System, Digital Image Communications, Radiological

Cleared on Dec 22, 1997 as substantially equivalent to K922164 (Olicon Imaging Systems, Inc., 1993) after a 67-day review. Its family tree reaches back 1 generation to 1993. 1 of the 382 devices in its family, counting itself, has a Class I recall. 380 later devices descend from it.

Decided: Dec 22, 1997
Review: 67 days
Class: Class I
Product code: LMD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K922164 (1993). 380 later devices descend from it, 6 citing it directly. 1 of the 382 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK922164 Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993
This deviceK973959 Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareOlicon Imaging Systems, Inc. · 1997
Descendant · cites it directly · 354 of its ownK981535 Focus Pilot Contouring WorkstationComputerized Medical Systems, Inc. · 1999
Descendant · 2 generations on · 353 of its ownK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
Descendant · 3 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
Descendant · 4 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
Descendant · 5 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009

Showing 5 of 380 descendants. See all descendants

Descendants cleared per year

1999high 39 (2025) · low 0 (2002)2026

Class I recalls in this family

K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…10 generations on · 2025

Most influential descendants

Showing 5 of 380 · See all

K981535Focus Pilot Contouring WorkstationComputerized Medical Systems, Inc. · 1999 · cites it directly354descendants
K052379Mim 3.5 (Circa)Mimvista Corp. · 2005 · 2 generations on353descendants
K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 3 generations on350descendants
K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 4 generations on287descendants
K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 5 generations on200descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922164	Raytel Digital Imaging Systems	Olicon Imaging Systems, Inc.	1993	—
0 (this device)	K973959	Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software	Olicon Imaging Systems, Inc.	1997	—
+1	K981535	Focus Pilot Contouring Workstation	Computerized Medical Systems, Inc.	1999	—
+2	K052379	Mim 3.5 (Circa)	Mimvista Corp.	2005	—
+3	K060816	Mim 4.0 (Neuro	Mimvista Corp.	2006	1
+4	K071964	Mim 4.1 (Seastar)	Mimvista Corp.	2007	2
+5	K091373	Syngo Trued	Siemens Medical Solutions USA, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	3	0
2000	1	0
2001	1	0
2005	4	0
2006	2	0
2007	4	0
2008	4	0
2009	2	0
2010	6	0
2011	8	0
2012	10	0
2013	6	0
2014	13	0
2015	13	0
2016	14	0
2017	18	0
2018	25	0
2019	25	0
2020	28	0
2021	26	0
2022	32	0
2023	31	0
2024	29	0
2025	39	1
2026	36	0

FIG. 1 — Lineage of K973959, 1993–2026Source: 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
*	K922164	Raytel Digital Imaging Systems Summary page 1 …ation Classification Name: System, Digital Image Communication, accessory Predicate Device: [21 CFR 807.92(a)(3) Applicant: OLICON IMAGING SYSTEMS INC. 510(k) Number: K922164 Device: RAYTEL DIGITAL IMAGING SYSTEMS Device Description: [21 CFR 807.92(a)(4)] The Olicon 02-Workstation and/or PACSView'™ sof…	Olicon Imaging Systems, Inc.	1993	—

Also cleared against K922164: 3 other devices →

What descends from it? (380)

See all 380

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

Number	Device	Applicant	Decided	Descendants
K981535	Focus Pilot Contouring Workstation	Computerized Medical Systems, Inc.	1999	354
K043146	Horizon Medical Imaging	Mckesson Medical Imaging Company	2005	27
K012327	Csist Dicom Gateway/Image Manager	Csist	2001	1
K001947	T.I.M.S., Version 2.00	Total Medical Information Management Systems, Inc.	2000	0
K992306	Samsung Raypax Display Workstation	Samsung Sds Co., Ltd.	1999	0
K984405	Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000	Intracom Corp.	1999	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 · 10 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, K981535 (Computerized Medical Systems, Inc., 1999) has gone furthest, with 354 descendants of its own.
3 other devices also cite its predicate K922164.

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 Olicon 02-Workstation and/or PACSView™ Software is a device that

receives digital images and data from various image sources, (including but

not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units,

Computed & Direct Radiographic devices, secondary capture devices,

scanners, imaging gateways, or other imaging sources). Images/data can

be stored, communicated, processed, and displayed within the workstation

and or across computer networks at distributed locations.

Typical users of this system are trained professionals, including but not

limited to physicians, nurses and medical technicians.

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/K973959 · printed Nov 5, 2026

Cite this page

510(k) Report. “K973959: Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973959

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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