Data / Medical devices / United States / Arcscan, Inc.
Arcscan, Inc.: FDA-registered device maker in Golden, CO, United States, 1 510(k) clearance
Arcscan, Inc. is registered with the FDA (registration 3006597338) in Golden, CO, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 2, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006597338
- Address
- 433 Park Point Drive, Suite 100, Golden, CO, United States, 80401
- Owner or operator
- ArcScan, Inc. (10049462)
- Roles
- Manufacturer
- First device listed
- May 15, 2019
- Registered through
- 2026
- Brand names listed
- Insight 100
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 2, 2016 | K153416 | ArcScan Insight 100 | IYO | Substantially Equivalent | Arcscan, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated February 2, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.