Nyquist.IQ— 510(k) K212890
Substantially EquivalentOmega Medical Imaging, LLC
FDA 510(k) clearance K212890 for Nyquist.IQ, Substantially Equivalent on 2021-12-13. Applicant: Omega Medical Imaging, LLC. Device class: 2.
Clearance details
- Applicant
- Omega Medical Imaging, LLC
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sanford, FL, US
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Adverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.