MAGENTIQ-COLO (ME-APDS)

K252178

Magentiq Eye, Ltd. · cleared 2025-10-03 · product code QNP · Gastroenterology-Urology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“ME-APDS (Magentiq Eye's Automatic Polyp Detection System) is intended to be used by endoscopists as an adjunct to the common video colonoscopy procedure (screening and surveillance), aiming to assist the endoscopist in identifying lesions during colonoscopy procedure by highlighting regions with visual characteristics consistent with different types of mucosal abnormalities that appear in the colonoscopy video during the procedure. Highlighted regions can be independently assessed by the endoscopist and appropriate action taken according to standard clinical practice. The system acquires the digital video output signal from the local endoscopy camera and processes the video frames. It runs deep machine learning and additional supporting algorithms in real time on the video frames in order to detect and identify regions having characteristics consistent with different types of mucosal abnormalities such as polyps.”
AlgorithmDeep machine learning and additional supporting algorithms for Computer-Aided Polyp Detection (CADe) engine.
source quote (p.5)
“It runs deep machine learning and additional supporting algorithms in real time on the video frames in order to detect and identify regions having characteristics consistent with different types of mucosal abnormalities such as polyps. Computer-Aided Polyp Detection (CADe) engine is the technological principle for both the subject and predicate devices.”
Adaptive (vs locked)No
source quote (p.6)
“The Al Polyp detection algorithm remains identical to the predicate device.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=252 images

endpoints: polyp detection frame-wise recall; polyp-wise recall; median of polyp coverage; False Positives Per Full Video (procedure) rate; Polyp-wise Recall evaluated a 1, 3, 5 and 7 consecutive frames as Precall1, Precall3, Precall5, and Precall7

Reported performance (1 observation)

sensitivity99.7CI [99.17%, 100.0%]
source quote (p.7)
“The system detects 99.7% to 99.7% (PRecall1 to PRecall7) of polyps verified by histology and 98.1% to 91.2% (PRecall1 to PRecall7) of the polyps when polyps without histology verification were included, showing the ability of the system to adequately aid in the detection of polyps when working with the MAGENTIQ-COLO.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Gastroenterology-Urology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252178