IDx-DR

K203629

Digital Diagnostics Inc. · cleared 2021-06-10 · product code PIB · Ophthalmic

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Artificial intelligence software as a medical device is the main technological principle for both the subject and predicate devices. The software as a medical device uses artificial intelligence technology to analyze specific disease features from fundus retinal images for diagnostic screening of diabetic retinopathy.”
AlgorithmArtificial intelligence software as a medical device
source quote (p.5)
“Artificial intelligence software as a medical device is the main technological principle for both the subject and predicate devices. The software as a medical device uses artificial intelligence technology to analyze specific disease features from fundus retinal images for diagnostic screening of diabetic retinopathy.”
Adaptive (vs locked)No
source quote (p.9)
“Future algorithm improvements will be made under a consistent medically relevant framework. A protocol was provided to mitigate the risk of algorithm changes leading to changes in the device technical specifications, which would lead to changes in false positive or false negative results. These changes could significantly affect clinical functionality or performance specifications directly associated with the intended use of the device, triggering the requirement for a new 510(k) premarket notification submission before commercial introduction.”
PCCPNo
source quote (p.9)
“Future algorithm improvements will be made under a consistent medically relevant framework. A protocol was provided to mitigate the risk of algorithm changes leading to changes in the device technical specifications, which would lead to changes in false positive or false negative results. These changes could significantly affect clinical functionality or performance specifications directly associated with the intended use of the device, triggering the requirement for a new 510(k) premarket notification submission before commercial introduction.”
Cybersecurity addressedYes
source quote (p.9)
“The cybersecurity considerations of data confidentiality, data integrity, data availability, denial of service attacks, and malware were adequately addressed utilizing platform controls, application controls, and procedure controls, and evidence was provided for the intended performance of the controls.”

Validation studies (1)

Bench

sample size not stated

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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) K213037 (decision 2022-06-17) from Digital Diagnostics Inc. for a matching device line ("IDx-DR v2.3") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K213037

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 Ophthalmic 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/K203629