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Arcscan, Inc.

United Statesfrom the FDA registration address FDA FEI 3006597338

Arcscan, Inc. is a medical device manufacturer, with 3 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 14 Nov 2026.

Devices
3
Registrations
FDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 2
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 3
Identifiers
  • FDA FEI 3006597338
  • DUNS 002151135

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI

What Arcscan, Inc. makes

Arcscan, Inc. manufactures ophthalmic ultrasound imaging systems designed for ocular diagnostics, including the ArcScan Insight 100. These devices are used to visualize internal eye structures through high-resolution ultrasound imaging, aiding in the assessment of conditions such as retinal detachment, intraocular tumors, and other posterior segment disorders.

The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway and listed in the FDA’s Unique Device Identifier (UDI) database.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

Company details

FDA FEI number
3006597338
DUNS number
002151135
Address
433 Park Point Drive, Suite 100, Golden, CO, 80401
Phone
720-287-8800

Frequently asked questions

How many devices does Arcscan, Inc. have in the registry?

The registry currently lists 3 devices for Arcscan, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Arcscan, Inc.'s devices?

Among its 3 most recently registered devices, Arcscan, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Arcscan, Inc.'s devices fall under?

Among its 3 most recently registered devices, the classes recorded for Arcscan, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Arcscan, Inc. in the registry?

The most recently registered devices listed for Arcscan, Inc. include ArcScan Insight 100 EyeSeal Disposable, ArcScan Insight 100 AS100 and ArcScan Insight 100.

Generated automatically from registry data and not verified by a human reviewer.