FDA.report

510(k) K220402

Device
VirtuOst
Applicant
O.N. Diagnostics
510(k) number
K220402
Product code
KGI
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-19
Date received
2022-02-11
Regulation
892.1170
Classification name
Densitometer, Bone
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
David Kopperdahl
Address
2150 Shattuck Ave. Suite 610 Berkeley CA US 94704 94704

FDA Registration Numbers

Source Documents

510(k) summary PDF

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