De Novo · Granted
GrantedNaviCam ProScan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ankon Technologies Co., Ltd. · QZF Gastrointestinal Capsule Endoscopy Analysis Software Device
Granted on Dec 12, 2023 as a new device type through De Novo after a 242-day review. 2 later devices descend from it.
- Decided
- Dec 12, 2023
- Review
- 242 days
- Class
- Class II
- Product code
- QZF
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
- This deviceDEN230027 NaviCam ProScanAnkon Technologies Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK254230 CapsoView (CVV); CapsoCloud (CLD)CapsoVision, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK250655 Deep Capsule® (Deep Capsule US)Digestaid - Artificial Intelligence Development SA · 2026
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 |
|---|---|---|---|---|---|
| 0 (this device) | DEN230027 | NaviCam ProScan | Ankon Technologies Co., Ltd. | 2023 | — |
| +1 | K254230 | CapsoView (CVV); CapsoCloud (CLD) | CapsoVision, Inc. | 2026 | — |
| +1 | K250655 | Deep Capsule® (Deep Capsule US) | Digestaid - Artificial Intelligence Development SA | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 0 |
Sources: FDA De Novo 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 QZF? 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 QZF device
- #1 K254230 CapsoView (CVV); CapsoCloud (CLD)score 12.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
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?
- Of its descendants, K254230 (CapsoVision, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QZF devicesQZF Gastrointestinal Capsule Endoscopy Analysis Software Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QZF
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QZF
Too few QZF 510(k)s in any year since 2007 to give a median.
Recalls per year · QZF
No recall names QZF since 2007.
Adverse event reports per year · QZF
No MAUDE report names QZF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
NaviCam ProScan is an artificial intelligent (AI) assisted reading tool designed to aid small bowel capsule endoscopy reviewers in decreasing the time to review capsule endoscopy images for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding. The clinician is responsible for conducting their own assessment of the findings of the AI-assisted reading through review of the entire video, as clinically…
Read the full statement (105 words)
NaviCam ProScan is an artificial intelligent (AI) assisted reading tool designed to aid small bowel capsule endoscopy reviewers in decreasing the time to review capsule endoscopy images for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding. The clinician is responsible for conducting their own assessment of the findings of the AI-assisted reading through review of the entire video, as clinically appropriate. ProScan also assists small bowel capsule endoscopy reviewers in identifying the digestive tract location (oral cavity and beyond, esophagus, stomach, small bowel) of the image in adults. This tool is not intended to replace clinical decision making.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230027 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230027: NaviCam ProScan.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230027
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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