510(k) Report

510(k) · Cleared

Cleared

Ziostation

K070205510(k) TraditionalCleared Mar 23, 200760-day reviewClass II21 CFR 892.2050

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

Ziosoft, Inc. · LLZ System, Image Processing, Radiological

Cleared on Mar 23, 2007 as substantially equivalent to K061326 (Barcoview Mis Edinburgh, 2006) after a 60-day review. Its family tree reaches back 1 generation to 2006. 3 later devices descend from it.

Decided
Mar 23, 2007
Review
60 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K061326 (2006). 3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant clearedK061326 · Voxar 3D Enterprise with Cardiametrix · Barcoview Mis Edinburgh · 200620052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K061326 · Voxar 3D Enterprise with Cardiametrix · Barcoview Mis Edinburgh · 20060
  1. Root · 1 generation backK061326 Voxar 3D Enterprise with CardiametrixBarcoview Mis Edinburgh · 2006
  2. This deviceK070205 ZiostationZiosoft, Inc. · 2007
  3. Descendant · cites it directly · 2 of its ownK151212 Ziostation2Qi Imaging, LLC · 2015
  4. Descendant · 2 generations on · 1 of its ownK181892 Ziostation2Ziosoft, Inc. · 2018
  5. Descendant · 3 generations on · 0 of its ownK200315 Ziostation2Ziosoft, Inc. · 2020

Most influential descendants

Showing 3 of 3 · See all
  • K151212Ziostation2Qi Imaging, LLC · 2015 · cites it directly2descendants
  • K181892Ziostation2Ziosoft, Inc. · 2018 · 2 generations on1descendant
  • K200315Ziostation2Ziosoft, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K061326Voxar 3D Enterprise with CardiametrixBarcoview Mis Edinburgh2006—
0 (this device)K070205ZiostationZiosoft, Inc.2007—
+1K151212Ziostation2Qi Imaging, LLC2015—
+2K181892Ziostation2Ziosoft, Inc.2018—
+3K200315Ziostation2Ziosoft, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201810
202010
FIG. 1 — Lineage of K070205, 2006–2020Source: 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), 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 LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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.

TypeNumberDeviceApplicantDecidedRecalls
*K061326Voxar 3D Enterprise with Cardiametrix
Summary page 1
…: System, Image Procession, Radiological 1.3 IDENTIFICATION OF LEGALLY MARKETED DEVICE Substantial equivalence is claimed to the Barco Voxar 3D Enterprise (K061326). 1.4 DEVICE DESCRIPTION ZIOSTATION is a software-only imaging workstation that installs on one or more of a cus…
Barcoview Mis Edinburgh2006—

Also cleared against K061326: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151212Ziostation2Qi Imaging, LLC20152

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?

  • Its one ancestor has no recall.
  • Of its descendants, K151212 (Qi Imaging, LLC, 2015) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K061326.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

ZIOSTATION is an image processing workstation software package designed to run on standard PC hardware. The required hardware consists of standard 'off-the-shelf' computer components. It receives image data from standard modalities (medical image scanning devices) or from image archives. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It can be used as a just a workstation or as a…

Read the full statement (134 words)

ZIOSTATION is an image processing workstation software package designed to run on standard PC hardware. The required hardware consists of standard 'off-the-shelf' computer components. It receives image data from standard modalities (medical image scanning devices) or from image archives. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It can be used as a just a workstation or as a client-server within a network. It is intended for use by trained medical imaging professionals to aid in their reading and review of such data.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammograpic images may only be interpreted using an FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by FDA.

Indications for use as stated in the FDA summary.

Also cleared against K061326

1 other device cites the same predicate.

  • K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc. · 2011

More from Ziosoft, Inc.

6 FDA decisions under this applicant name. See the company

  • K200315Ziostation2Ziosoft, Inc. · 2020
  • K181892Ziostation2Ziosoft, Inc. · 2018
  • K091262MR Cardiac Function AnalysisZiosoft, Inc. · 2009
  • K083446Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009
  • K083084CT Brain Perfusion for ZiostationZiosoft, Inc. · 2008

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K070205 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070205: Ziostation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070205

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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