GI Genius System 100 and GI Genius System 200

K231143

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

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
0
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 2026-07-08.

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/K231143