510(k) Report

510(k) · Cleared

Cleared

Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package

K040376510(k) SpecialCleared May 4, 200477-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

Sectra-Imtec AB · LLZ System, Image Processing, Radiological

Cleared on May 4, 2004 as substantially equivalent to K033712 (Sectra-Imtec AB, 2003) after a 77-day review. Its family tree reaches back 1 generation to 2003. 439 later devices descend from it.

Decided
May 4, 2004
Review
77 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K033712 (2003). 439 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2005: 11 descendants cleared2006: 5 descendants cleared2004: 2 descendants cleared2009: 13 descendants cleared2007: 7 descendants cleared2008: 11 descendants cleared2010: 9 descendants cleared2013: 12 descendants cleared2021: 39 descendants cleared2012: 10 descendants cleared2016: 23 descendants cleared2014: 15 descendants cleared2017: 25 descendants cleared2011: 6 descendants cleared2018: 31 descendants cleared2023: 29 descendants cleared2015: 20 descendants cleared2019: 22 descendants cleared2024: 35 descendants cleared2025: 36 descendants cleared2020: 24 descendants cleared2026: 26 descendants cleared2022: 28 descendants clearedK033712 · Modification to Sectra IDS5 Radiology Workstation - Version 10.1 · Sectra-Imtec AB · 2003200020052010201520202025
Descendants, by generation 1 generation forward: 7 descendants2 generations forward: 25 descendants3 generations forward: 32 descendants4 generations forward: 51 descendants5 generations forward: 64 descendants6 generations forward: 53 descendants7 generations forward: 46 descendants8 generations forward: 38 descendants9 generations forward: 32 descendants10 generations forward: 29 descendants11 generations forward: 27 descendants12 generations forward: 12 descendants13 generations forward: 14 descendants14 generations forward: 6 descendants15 generations forward: 2 descendants16 generations forward: 1 descendant K033712 · Modification to Sectra IDS5 Radiology Workstation - Version 10.1 · Sectra-Imtec AB · 20030+5+10+15
  1. Root · 1 generation backK033712 Modification to Sectra IDS5 Radiology Workstation - Version 10.1Sectra-Imtec AB · 2003
  2. This deviceK040376 Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D…Sectra-Imtec AB · 2004
  3. Descendant · cites it directly · 263 of its ownK043216 Cadstream Version 4.0Confirma, Inc. · 2005
  4. Descendant · 2 generations on · 123 of its ownK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005
  5. Descendant · cites it directly · 114 of its ownK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
  6. Descendant · 3 generations on · 101 of its ownK141620 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
  7. Descendant · 4 generations on · 99 of its ownK143089 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014

Showing 5 of 439 descendants. See all descendants

Descendants cleared per year

2004: 22005: 112006: 52007: 72008: 112009: 132010: 92011: 62012: 102013: 122014: 152015: 202016: 232017: 252018: 312019: 222020: 242021: 392022: 282023: 292024: 352025: 362026: 26
2004high 39 (2021) · low 2 (2004)2026

Most influential descendants

Showing 5 of 439 · See all
  • K043216Cadstream Version 4.0Confirma, Inc. · 2005 · cites it directly263descendants
  • K050846B-Cad System, Version 1.0The Medipattern Corporation · 2005 · 2 generations on123descendants
  • K042313Integradweb MPR/MipDynamic Imaging, Inc. · 2004 · cites it directly114descendants
  • K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 3 generations on101descendants
  • K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 4 generations on99descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K033712Modification to Sectra IDS5 Radiology Workstation - Version 10.1Sectra-Imtec AB2003—
0 (this device)K040376Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D PackageSectra-Imtec AB2004—
+1K043216Cadstream Version 4.0Confirma, Inc.2005—
+2K050846B-Cad System, Version 1.0The Medipattern Corporation2005—
+1K042313Integradweb MPR/MipDynamic Imaging, Inc.2004—
+3K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014—
+4K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
2005110
200650
200770
2008110
2009130
201090
201160
2012100
2013120
2014150
2015200
2016230
2017250
2018310
2019220
2020240
2021390
2022280
2023290
2024350
2025360
2026260
FIG. 1 — Lineage of K040376, 2003–2026Source: 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
*K033712Modification to Sectra IDS5 Radiology Workstation - Version 10.1
Summary page 1
…Classification Name: Image Processing System (LLZ) (21 CFR § 892.2050) Predicate Device: Applicant: Sectra Imtec AB 5 10(k) Number: K033712 Device: Sectra IDS5 Radiology Workstation Device Description: The Sectra IDS5 Radiology Workstation wi…
Sectra-Imtec AB2003—

Also cleared against K033712: 4 other devices →

What descends from it? (439)

See all 439

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

NumberDeviceApplicantDecidedDescendants
K043216Cadstream Version 4.0Confirma, Inc.2005263
K042313Integradweb MPR/MipDynamic Imaging, Inc.2004114
K050196Sectra IDS5 WorkstationSectra Imtec AB200536
K061672Synapse Mip/MPR Image Visualization Software ObliquusFujifilm Medical Systems U.S.A, Inc.200612
K042868Mammoreport Softcopy WorkstationSiemens Medical Solutions USA, Inc.20057
K041935DR Systems Pacs, Release 6.1Dr Systems, Inc.20041
K052537Catella Diagnostic Workstation, Version 4.0American Medical Sales, Inc.20050

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, K043216 (Confirma, Inc., 2005) has gone furthest, with 263 descendants of its own.
  • 4 other devices also cite its predicate K033712.

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.

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 Sectra IDS5 device is intended for the manipulation and displaying of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. Device options make possible mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc.; and teleconferencing. Lossy compressed mammographic images are…

Read the full statement (101 words)

The Sectra IDS5 device is intended for the manipulation and displaying of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.

Device options make possible mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc.; and teleconferencing.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

Indications for use as stated in the FDA summary.

Also cleared against K033712

4 other devices cite the same predicate.

  • K052537Catella Diagnostic Workstation, Version 4.0American Medical Sales, Inc. · 2005
  • K051743R2 Breast Imaging WorkstationR2 Technology, Inc. · 2005
  • K043216Cadstream Version 4.0Confirma, Inc. · 2005
  • K041935DR Systems Pacs, Release 6.1Dr Systems, Inc. · 20046 recalls

More from Sectra-Imtec AB

9 FDA decisions under this applicant name. See the company

  • K033712Modification to Sectra IDS5 Radiology Workstation - Version 10.1Sectra-Imtec AB · 2003
  • K031590Sectra Orthopedic PackageSectra-Imtec AB · 2003
  • K021527Sectra Osteoporosis PackageSectra-Imtec AB · 2002
  • K002936Modification to IDS5 Image Display SystemSectra-Imtec AB · 2000
  • K983447Wise (II) Image Management SystemSectra-Imtec AB · 19983 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/K040376 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040376: Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040376

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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