510(k) · Cleared
ClearedSafect Model Ver 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medic Vision Brain Technologies, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Dec 14, 2010 as substantially equivalent to K024028 (Context Vision AB, 2003) after a 305-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it.
- Decided
- Dec 14, 2010
- Review
- 305 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922470 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 2 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 1 generation backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- This deviceK100372 Safect Model Ver 1.0Medic Vision Brain Technologies, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK161625 PixelShineAlgomedica · 2016
Most influential descendants
Showing 1 of 1 · See all- K161625PixelShineAlgomedica · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −2 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −1 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| 0 (this device) | K100372 | Safect Model Ver 1.0 | Medic Vision Brain Technologies, Ltd. | 2010 | — |
| +1 | K161625 | PixelShine | Algomedica | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K024028 | Sharp View Image Enhancement SystemSummary page 1…ons system Classification: Class 11 Product Reason for 510(k) Submission Traditional 5 10(k) Submission Identification of Legally Marketed Predicate Device K024028 SharpView, manufactured by ContextVision Device Description The SafeCT is a software package of a PACS server, which is connected… | 2003 |
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 |
|---|---|---|---|
| K161625 | PixelShine | 2016 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K161625 (Algomedica, 2016) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K024028.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 SafeCT is intended for networking, communication, processing and enhancement of CT images in DICOM format. It is specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis. The device processing is not effective for lesion, mass or abnormalities of sizes less than 3 mm.
The SafeCT is not intended for use with or for diagnostic interpretation of Mammography images
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100372: Safect Model Ver 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100372
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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