510(k) · Cleared
ClearedSNT Image Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Navigation Technologies, Inc. · LLZ System, Image Processing, Radiological
Cleared on Oct 12, 1999 as substantially equivalent to K961637 (Philips Medical Systems (Cleveland), Inc., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Oct 12, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K905070 (1991). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 1 generation backK961637 Picker MR Workstations (Vistar,Montage and Oncall)Philips Medical Systems (Cleveland), Inc. · 1996
- This deviceK992354 SNT Image Analysis SystemSurgical Navigation Technologies, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK081797 Image Storage System, Model KSS-400Konan Medical, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK203244 CellChek 20 rcKonan Medical, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −1 | K961637 | Picker MR Workstations (Vistar,Montage and Oncall) | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| 0 (this device) | K992354 | SNT Image Analysis System | Surgical Navigation Technologies, Inc. | 1999 | — |
| +1 | K081797 | Image Storage System, Model KSS-400 | Konan Medical, Inc. | 2009 | — |
| +2 | K203244 | CellChek 20 rc | Konan Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K961637 | Picker MR Workstations (Vistar,Montage and Oncall)Summary page 1…e: Image Processing System (per 21 CFR section 892.2050) The above device is substantially equivalent to the MR Workstations manufactured by Picker International, Inc. (K961637) and the Acculmage Image Display Processor manufactured by Acculmage, Inc. (K961023). The substantial equivalence was established… | 1996 |
| * | K961023 | Aidp (Accuimage Image Display Processor)Summary page 1…ntially equivalent to the MR Workstations manufactured by Picker International, Inc. (K961637) and the Acculmage Image Display Processor manufactured by Acculmage, Inc. (K961023). The substantial equivalence was established by comparison of functions and features. This submission describes a system to dis… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081797 | Image Storage System, Model KSS-400 | 2009 | 1 |
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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K081797 (Konan Medical, Inc., 2009) has gone furthest, with 1 descendant 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 Image Analysis System is intended to provide a method of storing and providing remote viewing and analyzing access to diagnostic images via a LAN, the internet, or a modem. The system is also intended to provide the display of segmented anatomical structures based on the correlation of the image sets to atlas information. Examples of structures that may be segmented include but are not limited to: vertebral bodies, prostate, hippocampus, and the basal ganglia.
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/K992354 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992354: SNT Image Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992354
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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