510(k) · Cleared
ClearedNetra Workstation System & Netra MD Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scimage, Inc. · LMD System, Digital Image Communications, Radiological
Cleared on May 29, 1996 as substantially equivalent to K945428 (Multi-Dimensional Imaging, Inc., 1995) after an 84-day review. Its family tree reaches back 1 generation to 1995. 207 later devices descend from it.
- Decided
- May 29, 1996
- Review
- 84 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945428 (1995). 207 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK945428 Scribe (TM) Diagnostic Imaging WorkstationMulti-Dimensional Imaging, Inc. · 1995
- This deviceK960911 Netra Workstation System & Netra MD SoftwareScimage, Inc. · 1996
- Descendant · cites it directly · 166 of its ownK990426 Calcium ScoringSiemens Medical Solutions USA, Inc. · 1999
- Descendant · 2 generations on · 112 of its ownK043111 Plaqueview Software, Model CSPV-0001AToshiba America Medical Systems, In.C · 2004
- Descendant · 3 generations on · 111 of its ownK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 82 of its ownK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 45 of its ownK072737 CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007
Showing 5 of 207 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 207 · See all- K990426Calcium ScoringSiemens Medical Solutions USA, Inc. · 1999 · cites it directly166descendants
- K043111Plaqueview Software, Model CSPV-0001AToshiba America Medical Systems, In.C · 2004 · 2 generations on112descendants
- K061624Vitrea, Version 3.9Vital Images, Inc. · 2006 · 3 generations on111descendants
- K071331Vitrea Version 4.0Vital Images, Inc. · 2007 · 3 generations on82descendants
- K072737CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007 · 2 generations on45descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945428 | Scribe (TM) Diagnostic Imaging Workstation | Multi-Dimensional Imaging, Inc. | 1995 | — |
| 0 (this device) | K960911 | Netra Workstation System & Netra MD Software | Scimage, Inc. | 1996 | — |
| +1 | K990426 | Calcium Scoring | Siemens Medical Solutions USA, Inc. | 1999 | — |
| +2 | K043111 | Plaqueview Software, Model CSPV-0001A | Toshiba America Medical Systems, In.C | 2004 | — |
| +3 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| +3 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| +2 | K072737 | CSCS-001A Calcium Scoring Package | Toshiba America Medical Systems, In.C | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 11 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2012 | 9 | 0 |
| 2013 | 7 | 0 |
| 2014 | 8 | 0 |
| 2015 | 10 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 11 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 13 | 0 |
| 2023 | 13 | 0 |
| 2024 | 19 | 0 |
| 2025 | 21 | 0 |
| 2026 | 13 | 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 LMD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K945428 | Scribe (TM) Diagnostic Imaging WorkstationSummary page 1…ystem, Regulatory Class II 3. Predicate Device: SCRIBE™ Mexdical Image Processing System Multi-Dimensional Imaging, Inc., Newport Beach, CA FDA 510(k) Clearance Number: K 945428 4. Description of Device: The Netra™ Workstation System and NetraMD™™ Software is a Medical Image Processing System and digital i… | 1995 |
What descends from it? (207)
See all 2074 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?
- Its one ancestor has no recall.
- Of its descendants, K990426 (Siemens Medical Solutions USA, Inc., 1999) has gone furthest, with 166 descendants of its own.
How does its category compare?
All LMD devicesLMD System, Digital Image Communications, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMD
FDA has decided no LMD device since 2007.
Median 510(k) review, days · LMD
Too few LMD 510(k)s in any year since 2007 to give a median.
Recalls per year · LMD
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMD
16in 2025
MAUDE reports naming product code LMD, 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 | 0 | — | 2 | 1 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 1 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 2 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Netra™ Workstation System and NetraMD™ Software is intended for viewing and manipulation of high quality MRJ, CT, Ultrasound and X-ray electronic images as an aid in diagnosis for the trained medical practitioner. The NetraMD™ Software system in conjunction with NETRA™ Imaging Workstation system is used for: 1.) receiving and storing of image data from a ACR/NEMA DICOM 3.0 compatible medical imaging scanning device, ACC/ACR/NEMA (DICOM 3.0) Digital…
Read the full statement (189 words)
The Netra™ Workstation System and NetraMD™ Software is intended for viewing and manipulation of high quality MRJ, CT, Ultrasound and X-ray electronic images as an aid in diagnosis for the trained medical practitioner.
The NetraMD™ Software system in conjunction with NETRA™ Imaging Workstation system is used for:
1.) receiving and storing of image data from a ACR/NEMA DICOM 3.0 compatible medical imaging scanning device, ACC/ACR/NEMA (DICOM 3.0) Digital Interchange Standard for Cardiology (DISC95-96) storage media, direct digital transfer from a medical imaging scanning device and video frame capture from a medical imaging scanning device.
2.) displaying and reviewing received images in individual image windows with window/level and panning/zooming controls, reformatting of 3D and 4D volumes in orthogonal and oblique planes, volumetric presentation of 3D and 4D volumes using 3D reconstruction and rendering, measurement of distances, areas and volumes, and manual segmentation of structures of interest for 3D presentation.
3.) sending image data to ACR/NEMA DICOM 3.0 compatible equipment, ACC/ACR/NEMA (DICOM 3.0) Digital Interchange Standard for Cardiology storage media, printer, scanning device monitor, independent monitor or other device for purpose of communication, archiving, review and display of medical diagnostic images.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960911: Netra Workstation System & Netra MD Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960911
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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