510(k) · Cleared
Recalled · Class II · 2017DR Systems Pacs, Release 6.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dr Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 16, 2004 as substantially equivalent to K033400 (Ge Medical Systems W-400, 2003) and 2 other predicates after a 28-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Aug 16, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 4 generations to K913770 (1991). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 3 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 2 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 1 generation backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- This deviceK041935 DR Systems Pacs, Release 6.1Dr Systems, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK081168 Brit Pacs SystemsBrit Systems, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K081168Brit Pacs SystemsBrit Systems, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −3 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −2 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −1 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| 0 (this device) | K041935 | DR Systems Pacs, Release 6.1 | Dr Systems, Inc. | 2004 | — |
| +1 | K081168 | Brit Pacs Systems | Brit Systems, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033400 | Seno AdvantageSummary page 1…odel: Seno Advantage Windows Review Workstation Manufacturer: General Electric Medical Systems 510 (k) Number: K033400 Model: Sectra IDS5 Radiology Workstation Manufacturer: Sectra lmtec AB 510 (k) Numbe… | 2003 |
| * | K033712 | Modification to Sectra IDS5 Radiology Workstation - Version 10.1Summary page 1…K033400 Model: Sectra IDS5 Radiology Workstation Manufacturer: Sectra lmtec AB 510 (k) Number: K033712 as modified by K040376 4. Device Description: The DR Systems Dominator Reading Station is a multi-modality PC-driven review w… | 2003 |
| * | K040376 | Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D PackageSummary page 1…Model: Sectra IDS5 Radiology Workstation Manufacturer: Sectra lmtec AB 510 (k) Number: K033712 as modified by K040376 4. Device Description: The DR Systems Dominator Reading Station is a multi-modality PC-driven review workstation. It includes… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081168 | Brit Pacs Systems | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 14, 2017 | Class II | Z-3105-2017 | Process design | The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. |
| Aug 7, 2017 | Class II | Z-2566-2018 | Process design | The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. |
| Apr 8, 2016 | Class II | Z-1385-2017 | Software design | The software is not adding the correct tomo image. |
| Apr 8, 2016 | Class II | Z-1426-2017 | Software design | Reports were missing demographic header information when they were faxed to referring physicians. |
| Oct 15, 2015 | Class II | Z-0939-2017 | Software design | The software fails to associate to the correct MG image if there are two images for the same view. |
| Jul 23, 2015 | Class II | Z-2551-2016 | Software design | The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K081168 (Brit Systems, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K033400.
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 DR Systems PACS, Release 6.1 is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. The DR Systems PACS interfaces to various storage and printing devices using DICOM or similar interface standards. The DR Systems PACS displays, stores, prints, and telecommunicates images from a number of…
Read the full statement (158 words)
The DR Systems PACS, Release 6.1 is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. The DR Systems PACS interfaces to various storage and printing devices using DICOM or similar interface standards.
The DR Systems PACS displays, stores, prints, and telecommunicates images from a number of medical modalities, including but not limited to MRI, CT, US, PET, DXA (bone densitometry), imaging, computed radiography, digital radiography, digitized films, digital photographs, mammographic images, and processed data from FDA-cleared third party image processing systems, including FDA-cleared systems for computer-aided detection and advanced image processing (e.g. 3-D processed images such as those produced by Voxar Corp.).
Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041935 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041935: DR Systems Pacs, Release 6.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041935
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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