FDA Product Index

This selected index is generated from data/fda-products.csv. It links to specific historical US authorization records used as teaching examples. It is not a complete current inventory, a purchasing recommendation, or a statement that every version of a named product has the same indication. The non-CXR records were reviewed for this edition on 22 September 2026.

Modality	Device	Vendor	Submission	Indication summary	Boundary	FDA record
cxr	Critical Care Suite	GE HealthCare	K183182 (2019)	Frontal CXR pneumothorax triage; adult-size patients	Notification only; physician image review retained; historical clearance checked 2026-09-04	Source
cxr	Red Dot	Behold.ai	K191556 (2020)	Adult CXR suspected pneumothorax case prioritization	Not localization or pneumothorax rule-out; historical clearance checked 2026-09-04	Source
cxr	Lunit INSIGHT CXR Triage	Lunit	K211733 (2021)	Adult CXR pleural effusion and/or pneumothorax triage	Passive case-level prioritization; not standalone diagnosis; historical clearance checked 2026-09-04	Source
ct	ContaCT	Viz.ai	DEN170073; De Novo	Parallel notification of suspected LVO on supported brain CTA	Triage; diagnostic image review retained; original historical indication	Source
ct	BriefCase	Aidoc	K180647; 510(k)	Suspected intracranial hemorrhage triage on noncontrast head CT	This record is not a combined ICH/PE indication	Source
mri	NeuroQuant	CorTechs Labs	K061855; 510(k)	Labeling and volumetric quantification of brain structures on MR images	Original quantitative software record; not autonomous etiologic diagnosis	Source
us	Caption Guidance	Bay Labs / Caption Health	DEN190040; De Novo	Guidance for acquiring specified adult 2D transthoracic echo views	Supported hardware and users; acquisition assistance rather than diagnosis	Source
mammo	Transpara 2.1.0	ScreenPoint Medical	K241831; 510(k)	Physician reading assistance for supported screening mammography and DBT	Concurrent assistance; not autonomous management or universal scanner support	Source
nm	SubtlePET	Subtle Medical	K182336; 510(k)	Processing including noise reduction for specified FDG and amyloid PET images	Supported PET and hybrid inputs; not general tracer diagnosis	Source
ophtho	IDx-DR	IDx	DEN180001; De Novo	Autonomous DR screening in the specified adult diabetic population	Original indication includes age 22 or older and no prior DR diagnosis; compatible camera required	Source
video	GI Genius	Cosmo Artificial Intelligence	DEN200055; De Novo	Real-time colorectal mucosal lesion detection assistance during colonoscopy	Supported adult workflow and hardware; no histology or autonomous treatment	Source
path	Paige Prostate	Paige.AI	DEN200080; De Novo	Aid for cancer detection in specified prostate needle-biopsy H&E WSI	Original workflow follows pathologist review; not grading or tumor measurement	Source

Read the record behind the product name

A 510(k) clearance, a De Novo authorization, and premarket approval are distinct regulatory pathways. Use the language appropriate to the actual record. The book’s inherited chapter heading “FDA-cleared AI products” is a convenient category heading; individual tables explicitly identify De Novo records rather than calling every authorization a clearance.

Start with the submission number, device name, intended use, indications, compatible inputs and hardware, user population, and limitations. Then determine whether the local workflow matches those conditions. Do not attach a later product-family claim to an earlier submission merely because the names are similar.

Claimed role	Question to resolve
Triage or notification	Does it change worklist priority, and what diagnostic review remains required?
Detection assistance	What findings, images, users, and reading configuration are supported?
Acquisition guidance	Which views and hardware are covered, and who judges adequacy?
Quantification	What is measured, in which units, and what diagnosis is not established?
Autonomous screening	Which population, acquisition, target condition, and no-result pathway are specified?
Image enhancement	Which acquisitions and quantitative or diagnostic claims are supported?

The FDA AI-enabled device list provides a broader discovery resource and explains that it is not comprehensive. Use its submission links and the applicable current labeling when evaluating a real deployment. Authorization does not eliminate the need to verify interoperability, local workflow, training, monitoring, and change management.

Absence from this appendix means only that no example has been curated here. It is not evidence that a modality lacks authorized devices. Products outside the United States require review under the relevant jurisdiction rather than extrapolation from this index.