FDA.report

510(k) K212890

Device
Nyquist.IQ
Applicant
Omega Medical Imaging, LLC
510(k) number
K212890
Product code
JAA
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-13
Date received
2021-09-10
Regulation
892.1650
Classification name
System, X-Ray, Fluoroscopic, Image-Intensified
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
John Newman
Address
3400 St. Johns Pkwy., Suite 1020 Sanford FL US 32771 32771

FDA Registration Numbers

Source Documents

510(k) summary PDF

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