GI Genius System 100 and GI Genius System 200

K231143

Cosmo Artificial Intelligence - AI Ltd · cleared 2023-05-19 · product code QNP · Gastroenterology-Urology

FDA 510(k) summary for GI Genius System 100 and GI Genius System 200 (K231143)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
1
Performance observations
3
Product code
QNP
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“GI Genius is an artificial intelligence-based device that has been trained to process colonoscopy images containing regions consistent with colorectal lesions like polyps, including those with flat (non-polypoid) morphology. The device includes hardware to support interfacing with video endoscopy systems.”
Algorithmartificial intelligence-based device
source quote (p.5)
“GI Genius is an artificial intelligence-based device that has been trained to process colonoscopy images containing regions consistent with colorectal lesions like polyps, including those with flat (non-polypoid) morphology.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

n=42 cases

endpoints: Lesion-based sensitivity; Frame level performance; True positive rate per frame; False positive rate per frame; Frame-based TPr/FPr ROC curve, AOC; False positive clusters per patient

standards: IEC 60601-1, IEC 60601-1-2

Reported performance (3 observations)

sensitivity86.5
source quote (p.8)
“Lesion-based sensitivity 86.5%”
aurocas written: “auc”0.796
source quote (p.8)
“Frame-based TPr/FPr ROC curve, AOC 0.796”
sensitivityas written: “True positive rate per frame”58.3
source quote (p.8)
“True positive rate per frame Mean: 58.30%”

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
1
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K241887 (decision 2024-07-25) from Cosmo Artificial Intelligence - AI Ltd for a matching device line ("GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K241887

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K233964 (decision 2024-01-12) from Cosmo Artificial Intelligence - AI Ltd for a matching device line ("GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K233964

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 2026-09-02.

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.

Related FDA clearances

More AI/ML devices under product code QNP

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

SKOUT system

K253664

Iterative Health

cleared 2025-12-22

MAGENTIQ-COLO (ME-APDS)

K252178

Magentiq Eye, Ltd.

cleared 2025-10-03

CADDIE

K252586

Odin Medical Limited

cleared 2025-09-12

SKOUT system

K251126

Iterative Health

cleared 2025-05-09

MAGENTIQ-COLO (ME-APDS)

K244023

Magentiq Eye LTD

cleared 2025-01-24

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)

K241887

Cosmo Artificial Intelligence - AI Ltd

cleared 2024-07-25

CADDIE

K240044

Odin Medical Limited

cleared 2024-07-24

SKOUT® system

K241508

Iterative Scopes, Inc.

cleared 2024-07-03

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K231143