510(k) · Cleared
ClearedGentle Colon (Revision 2.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rendoscopy, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 18, 2006 as substantially equivalent to K954355 (General Electric Co., 1995) after a 108-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 18, 2006
- Review
- 108 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954355 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- This deviceK061532 Gentle Colon (Revision 2.0)Rendoscopy, Inc. · 2006
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) | K061532 | Gentle Colon (Revision 2.0) | Rendoscopy, Inc. | 2006 | — |
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…. Name of Device: Rendoscopy Gentle Colon, revision 2.0 3. Predicate Device Information: G.E. Navigator, 510(k) #K 954355 This system is anadd-on to the Advantage Windows Workstation. 4. Device Description: The Gentle Colon con… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 9 other devices also cite its predicate K954355.
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?
Rendoscopy's Gentle Colon, revision 2.0, is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM compliant CT scans for the purpose of complete colonic mucosa assessment. The user is capable to assure the colonic mucosa image quality through the following provisions built into the software: * 3D visualization (3D detection, 2D assessment) * No blind areas behind colonic folds due to splitting colon…
Read the full statement (192 words)
Rendoscopy's Gentle Colon, revision 2.0, is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM compliant CT scans for the purpose of complete colonic mucosa assessment. The user is capable to assure the colonic mucosa image quality through the following provisions built into the software:
* 3D visualization (3D detection, 2D assessment)
* No blind areas behind colonic folds due to splitting colon techniques
* Multi-path tracking system allows path finding over collapsed or liquid-filled parts of the colon
* The software provides full presentation of cross sectional imaging, such as axial, sagittal, frontal, oblique, intra-luminal, split colon, topogram view, external and unrolled view of the colon and double contrast visualization
It also includes an automatic report creation facility and is intended for use by Radiologists, Clinicians and referring Physicians to process, render, review, archive, print and distribute colon image study reports utilizing PC hardware.
The target population of the Gentle Colon 3D application is the adult patient. It is intended to be used as adjunctive to standard radiology practices for diagnosis, such as the double contrast/barium enema, of the colon.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061532 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061532: Gentle Colon (Revision 2.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061532
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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