510(k) · Cleared
ClearedEpi-Scope Option for Q Series CT Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 21, 1997 as substantially equivalent to K954355 (General Electric Co., 1995) after a 302-day review. Its family tree reaches back 1 generation to 1995. 9 later devices descend from it.
- Decided
- Mar 21, 1997
- Review
- 302 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954355 (1995). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- This deviceK962010 Epi-Scope Option for Q Series CT SystemsPhilips Medical Systems (Cleveland), Inc. · 1997
- Descendant · cites it directly · 8 of its ownK990241 Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore…Accuimage Diagnostics Corp. · 1999
- Descendant · cites it directly · 1 of its ownK063221 Medweb Advanced 3D Web PacsNexsys Electronics, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK024149 PrimelungAccuimage Diagnostics Corp. · 2003
- Descendant · 2 generations on · 0 of its ownK082336 XR-ExpressNew Mexico Software, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK070868 LMS-Lung/TrackMedian Technologies · 2007
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K990241Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope…Accuimage Diagnostics Corp. · 1999 · cites it directly8descendants
- K063221Medweb Advanced 3D Web PacsNexsys Electronics, Inc. · 2006 · cites it directly1descendant
- K024149PrimelungAccuimage Diagnostics Corp. · 2003 · 2 generations on1descendant
- K082336XR-ExpressNew Mexico Software, Inc. · 2008 · 2 generations on0descendants
- K070868LMS-Lung/TrackMedian Technologies · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| 0 (this device) | K962010 | Epi-Scope Option for Q Series CT Systems | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| +1 | K990241 | Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze… | Accuimage Diagnostics Corp. | 1999 | — |
| +1 | K063221 | Medweb Advanced 3D Web Pacs | Nexsys Electronics, Inc. | 2006 | — |
| +2 | K024149 | Primelung | Accuimage Diagnostics Corp. | 2003 | — |
| +2 | K082336 | XR-Express | New Mexico Software, Inc. | 2008 | — |
| +3 | K070868 | LMS-Lung/Track | Median Technologies | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K954355 | Advantage Windows 3D with Navigator OptionSummary page 1…current state-of- the-art technology, therefore, is equivalent to legally marketed Advantage 3D Navigator Option manufactured by General Electric in Document Control No. K954355. Picker has reviewed all known information and performed an investigation as to the causes of safety/effectiveness concerning t… | 1995 |
What descends from it? (9)
2 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?
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 epi-Scope Option will be used in a Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This device may include signal analysis and display equipment, patient equipment supports, components and accessories.
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/K962010 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962010: Epi-Scope Option for Q Series CT Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962010
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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