510(k) · Cleared
ClearedCapsoView (CVV); CapsoCloud (CLD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CapsoVision, Inc. · QZF Gastrointestinal Capsule Endoscopy Analysis Software Device
Cleared on Sep 25, 2026 as substantially equivalent to DEN230027 (Ankon Technologies Co., Ltd., 2023) after a 270-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Sep 25, 2026
- Review
- 270 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 deviceK254230 CapsoView (CVV); CapsoCloud (CLD)CapsoVision, Inc. · 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) | K254230 | CapsoView (CVV); CapsoCloud (CLD) | CapsoVision, Inc. | 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 K250655 Deep Capsule® (Deep Capsule US)score 11.0 · 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…ly Marketed Predicate Devices 21 CFR 807.92(a)(3) Primary Predicate Device: Ankon Technologies Co., Ltd. NaviCam ProScan (DEN230027, Product Code: QZF) Reference Device: DigestAID - Artificial Intelligence Developme… | 2023 |
| † | K250655 | Deep Capsule® (Deep Capsule US) | 2026 |
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?
CapsoView is a software application for the download, transcode, and review of videos from CapsoCam Plus Capsule Endoscopes, and the generation of capsule endoscopy reports. CapsoCloud is a cloud-based software application for the review of videos from CapsoCam Plus Capsule Endoscopes, and the generation of capsule endoscopy reports. The software includes artificial intelligence (AI) tools for video analysis designed to aid clinicians in the review of…
Read the full statement (188 words)
CapsoView is a software application for the download, transcode, and review of videos from CapsoCam Plus Capsule Endoscopes, and the generation of capsule endoscopy reports.
CapsoCloud is a cloud-based software application for the review of videos from CapsoCam Plus Capsule Endoscopes, and the generation of capsule endoscopy reports.
The software includes artificial intelligence (AI) tools for video analysis designed to aid clinicians in the review of small bowel capsule endoscopy images collected from adult and pediatric patients over two years of age, in whom the capsule endoscopy images were obtained for suspected small bowel bleeding. The “AI Highlights” tool aids small bowel capsule endoscopy reviewers by decreasing the time to review capsule endoscopy images. The “Suggested Landmarks” tool assists reviewers in the identification of the digestive tract location (esophagus, stomach, small bowel, and colon). The “Green Detection” tool identifies and sequesters obscured, uninterpretable frames (e.g., obscured by debris, bile, or bubbles) to streamline the review process.
The AI tools are not intended to replace the clinician's diagnostic interpretation. Clinicians are responsible for conducting their own assessment of the AI-assisted findings by reviewing the entire video as clinically appropriate.
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/K254230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254230: CapsoView (CVV); CapsoCloud (CLD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254230
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026