510(k) · Cleared
ClearedModification to Sectra IDS5 Radiology Workstation - Version 10.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sectra-Imtec AB · LLZ System, Image Processing, Radiological
Cleared on Dec 23, 2003 after a 27-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 442 later devices descend from it.
- Decided
- Dec 23, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
442 later devices descend from it, 5 citing it directly.
- This deviceK033712 Modification to Sectra IDS5 Radiology Workstation - Version 10.1Sectra-Imtec AB · 2003
- Descendant · cites it directly · 439 of its ownK040376 Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D…Sectra-Imtec AB · 2004
- Descendant · cites it directly · 263 of its ownK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- Descendant · 2 generations on · 123 of its ownK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005
- Descendant · 2 generations on · 114 of its ownK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- Descendant · 3 generations on · 101 of its ownK141620 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
Showing 5 of 442 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 442 · See all- K040376Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D PackageSectra-Imtec AB · 2004 · cites it directly439descendants
- 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 · 2 generations on114descendants
- K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 3 generations on101descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033712 | Modification to Sectra IDS5 Radiology Workstation - Version 10.1 | Sectra-Imtec AB | 2003 | — |
| +1 | K040376 | Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package | Sectra-Imtec AB | 2004 | — |
| +1 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| +2 | K050846 | B-Cad System, Version 1.0 | The Medipattern Corporation | 2005 | — |
| +2 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| +3 | K141620 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 12 | 0 |
| 2006 | 5 | 0 |
| 2007 | 8 | 0 |
| 2008 | 11 | 0 |
| 2009 | 13 | 0 |
| 2010 | 9 | 0 |
| 2011 | 6 | 0 |
| 2012 | 10 | 0 |
| 2013 | 12 | 0 |
| 2014 | 15 | 0 |
| 2015 | 20 | 0 |
| 2016 | 23 | 0 |
| 2017 | 25 | 0 |
| 2018 | 31 | 0 |
| 2019 | 22 | 0 |
| 2020 | 24 | 0 |
| 2021 | 39 | 0 |
| 2022 | 28 | 0 |
| 2023 | 29 | 0 |
| 2024 | 35 | 0 |
| 2025 | 36 | 0 |
| 2026 | 26 | 0 |
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 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K003308 | FDA’s K003308 is Microlife Digital Infrared Ear Thermometer, IR1DAI, IR1DB1, IR1DD1 Our reading of the summary gave K003308, FDA’s number for Microlife Digital Infrared Ear Thermometer, IR1DAI… (Microlife Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Sectra IDS5 Radiology Workstation - Version 10.1”. Kept off the family tree. Summary page 1…Classification Name: Image Processing System (LLZ) (21 CFR § 892.2050) Predicate Device: Applicant: Sectra Imtec AB 510(k) Number: K0033088 Device: Sectra IDS5 Radiology Workstation - Version 10.1 Device Description: The IDS5 Radiology W… | 2000 |
What descends from it? (442)
See all 4425 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K040376 (Sectra-Imtec AB, 2004) has gone furthest, with 439 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The Sectra IDS device is intended for the manipulation and displaying of x-ray 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.
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.
https://510kreport.com/device/K033712 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033712: Modification to Sectra IDS5 Radiology Workstation - Version 10.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033712
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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