510(k) · Cleared
ClearedDeep Capsule® (Deep Capsule US)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digestaid - Artificial Intelligence Development SA · QZF Gastrointestinal Capsule Endoscopy Analysis Software Device
Cleared on Mar 12, 2026 as substantially equivalent to DEN230027 (Ankon Technologies Co., Ltd., 2023) after a 372-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Mar 12, 2026
- Review
- 372 days
- Class
- Class II
- Product code
- QZF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230027 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230027 NaviCam ProScanAnkon Technologies Co., Ltd. · 2023
- This deviceK250655 Deep Capsule® (Deep Capsule US)Digestaid - Artificial Intelligence Development SA · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230027 | NaviCam ProScan | Ankon Technologies Co., Ltd. | 2023 | — |
| 0 (this device) | K250655 | Deep Capsule® (Deep Capsule US) | Digestaid - Artificial Intelligence Development SA | 2026 | — |
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 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
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 |
|---|---|---|---|
| * | DEN230027 | NaviCam ProScanSummary page 5…QZF Review Panel Gastroenterology/Urology 807.92(a)(3) – Predicate Device De Novo Number DEN230027 Manufacturer Ankon Technologies Co., Ltd CFR 21 CFR § 876.1540 Classifi… | 2023 |
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.
- 1 other device also cites its predicate DEN230027.
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. 2026, 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?
Deep Capsule® is an artificial intelligence (Al) 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 Al-assisted reading through review of the entire video, as clinically appropriate. This tool is not intended to replace clinical decision-making.
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/K250655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250655: Deep Capsule® (Deep Capsule US).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250655
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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