Videa Dental Assist

K232384

VideaHealth, Inc. · cleared 2023-12-15 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.12)
“Not applicable. The subject device is a software-only device.”
Algorithmcloud-based AI-powered medical device, Supervised Deep Learning
source quote (p.6)
“Videa Dental Assist (VDA) software is a cloud-based AI-powered medical device for the automatic detection of the features listed in the Indications For Use statement in dental radiographs. Supervised Deep Learning”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

n=1,445 images · 35 site(s)

endpoints: sensitivity; specificity

standards: ISO 14971:2019 Application of Risk Management to Medical Devices, AAMI CR34971:2022 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning, IEC 62304 Edition 1.1 2015-06 Consolidated Version: Medical Device Software - Software Life Cycle Processes, Good Machine Learning Practice for Medical Device Development: Guiding Principles October 2021, FDA Premarket Assessment of Pediatric Medical Devices Guidance Document (March 24, 2014)

Reader study (MRMC)

n=378 images · 25 site(s)

endpoints: diagnostic accuracy of readers aided by VDA is superior to reader accuracy when unaided by VDA, as determined by the AFROC Figure of Merit (AFROC FOM)

standards: FDA's Multiple Endpoints in Clinical Trials Guidance for Industry (October 2022)

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
-100%
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) K251002 (decision 2025-09-19) from VideaHealth Inc. for a matching device line ("Videa Dental AI") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251002

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 Radiology 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/K232384