510(k) Report

510(k) · Cleared

Cleared

Topacs

K063294510(k) TraditionalCleared Jan 24, 200784-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

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

Cleared on Jan 24, 2007 as substantially equivalent to K030781 (Eastman Kodak Company, 2003) and 2 other predicates after an 84-day review. Its family tree reaches back 4 generations to 1996.

Decided
Jan 24, 2007
Review
84 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K955092 (1996). 10 ancestors in all, the oldest K925965 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 2 other ancestors2001: 2 other ancestors1994: 1 other ancestor1993: 1 other ancestorK955092 · Accurad Image Management System, Autorad, Regustration Station, Archive Server, Print Spooler, Analog & Digital Acquire · Cemax-Icon, Inc. · 1996K963610 · Aki Compacs Data Compresion Module for Diagnostic Images · A.L.I. Technologies, Inc. · 1996K982563 · Ultrapro Model 98 · Ramsoft, Inc. · 1998K031562 · Ramsoft Pacs, Model 3.0 · Ramsoft, Inc. · 20031990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 2 other ancestors K031562 · Ramsoft Pacs, Model 3.0 · Ramsoft, Inc. · 2003K982563 · Ultrapro Model 98 · Ramsoft, Inc. · 1998K963610 · Aki Compacs Data Compresion Module for Diagnostic Images · A.L.I. Technologies, Inc. · 1996K955092 · Accurad Image Management System, Autorad, Regustration Station, Archive Server, Print Spooler, Analog & Digital Acquire · Cemax-Icon, Inc. · 19960
  1. Root · 4 generations backK955092 Accurad Image Management System, Autorad, Regustration Station…Cemax-Icon, Inc. · 1996
  2. 3 generations backK963610 Aki Compacs Data Compresion Module for Diagnostic ImagesA.L.I. Technologies, Inc. · 1996
  3. 2 generations backK982563 Ultrapro Model 98Ramsoft, Inc. · 1998
  4. 1 generation backK031562 Ramsoft Pacs, Model 3.0Ramsoft, Inc. · 2003
  5. This deviceK063294 TopacsRadiological Specialists, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K955092Accurad Image Management System, Autorad, Regustration Station, Archive…Cemax-Icon, Inc.1996—
−3K963610Aki Compacs Data Compresion Module for Diagnostic ImagesA.L.I. Technologies, Inc.1996—
−2K982563Ultrapro Model 98Ramsoft, Inc.1998—
−1K031562Ramsoft Pacs, Model 3.0Ramsoft, Inc.2003—
0 (this device)K063294TopacsRadiological Specialists, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
200120
200320
FIG. 1 — Lineage of K063294, 1996–2007Source: 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? (3)

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
*K030781Kodak Directview Pacs/Image Management System, Kodak Directview Workflow Manager,Kodak…
Summary page 2
…s CR, CT, DR, MR and other devices) and information systems. * Technological Characteristics (comparison with predicate device): * Predicated Device: k030781: KODAK DirectView 5 k023460: PACSPLUS k031562: Ramsoft PACS * Statement of Substantial Equivalence: Thoth ToPACS…
Eastman Kodak Company2003—
*K023460Pacsplus
Summary page 2
…and information systems. * Technological Characteristics (comparison with predicate device): * Predicated Device: k030781: KODAK DirectView 5 k023460: PACSPLUS k031562: Ramsoft PACS * Statement of Substantial Equivalence: Thoth ToPACS is substantially equivalent to Ram…
Medical Standard Co., Ltd.2003—
*K031562Ramsoft Pacs, Model 3.0
Summary page 2
…* Technological Characteristics (comparison with predicate device): * Predicated Device: k030781: KODAK DirectView 5 k023460: PACSPLUS k031562: Ramsoft PACS * Statement of Substantial Equivalence: Thoth ToPACS is substantially equivalent to RamSoft PACS, PACSPLUS, and…
Ramsoft, Inc.2003—

Also cleared against K030781: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
  • None of the 10 ancestors has a recall.
  • 2 other devices also cite its predicate K030781.

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?

The Thoth ToPACS is an image management system whose intended use is to

provide (scaleable ) DICOM compatible PACS solutions for hospital and

related institutions/sites, which will archive/ distribute/ retrieve and display

images and data from all hospital modalities (such as CR, CT, DR, MR and

other devices) and information systems.

Lossy Compressed Mammographic Images and Digitized Film Screen Images

must not be reviewed for primary Image interpretations. Mammographic

Images may only be interpreted using an FDA approved monitor that offers at

least 5 Mpixel resolution and meets other specifications reviewed and accepted

by FDA

Indications for use as stated in the FDA summary.

Also cleared against K030781

2 other devices cite the same predicate.

  • K062878Ezpacs, Version 3.0Advanced Imaging Solutions, LLC · 2007
  • K042292Isite PacsStentor, Inc. · 20047 recalls

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/K063294 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063294: Topacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063294

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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