MAGENTIQ-COLO (ME-APDS)

K244023

Magentiq Eye LTD · cleared 2025-01-24 · product code QNP · Gastroenterology-Urology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Common or Usual Name: Computer aided detection software for colorectal polyps”
Algorithmdeep machine learning and additional supporting algorithms
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.”
Adaptive (vs locked)No
source quote (p.6)
“The AI algorithm remains identical to the predicate device.”
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: Pixel-level comparison of degradation of image quality; Software validation; EMC testing; Electrical safety testing

standards: IEC 60601-1-2:2014 [Including AMD 1:2021], TR 60601-4-2 Edition 1.0 2016-05, IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION

Retrospective clinical

n=702 other

endpoints: ME-APDS recall and false positive performance; Polyp-wise Recall; False Positives Per Full Video (procedure) rate

Reported performance (5 observations)

sensitivity0.731CI [70.56%, 75.75%]
source quote (p.7)
“73.1% [70.56%, 75.75%]”
sensitivityas written: “Polyp-wise Recall (PRecall1)”0.979CI [96.63%, 98.94%]
source quote (p.7)
“97.9% [96.63%, 98.94%]”
sensitivityas written: “Polyp-wise Recall (PRecall3)”0.953CI [93.39%, 96.96%]
source quote (p.7)
“95.3% [93.39%, 96.96%]”
sensitivityas written: “Polyp-wise Recall (PRecall5)”0.932CI [91.01%, 95.15%]
source quote (p.7)
“93.2% [91.01%, 95.15%]”
sensitivityas written: “Polyp-wise Recall (PRecall7)”0.906CI [88.19%, 92.91%]
source quote (p.7)
“90.6% [88.19%, 92.91%]”

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252178 (decision 2025-10-03) from Magentiq Eye, Ltd. for a matching device line ("MAGENTIQ-COLO (ME-APDS)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252178

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/K244023