Nyquist.IQ
FDA 510(k) K212890 · Omega Medical Imaging, LLC
510(k) numberK212890
Submission
- Device name
- Nyquist.IQ
- Applicant
- Omega Medical Imaging, LLC
Sanford, FL, US - Received
- September 10, 2021
- Decision date
- December 13, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K242488 | Soteria E-ViewJAA · Traditional | Omega Medical Imaging, LLC | 01/06/2025SE |
| K242948 | Adora DRFi (04550010)JAA · Traditional | Nrt X-Ray A/S | 12/23/2024SE |
| K233380 | TRIDENT Mobile Fluoroscopy SystemJAA · Traditional | Dornier Medtech America | 06/26/2024SE |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA · Special | Philips Medical Systems Dmc GmbH | 01/11/2024SE |
| K232910 | CombiDiagnost R90JAA · Special | Philips Medical Systems Dmc GmbH | 10/19/2023SE |
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| K220871 | NautilusJAA · Special | Dornier Medtech America, Inc. | 04/18/2022SE |
| K212837 | ProxiDiagnost N90JAA · Special | Philips Medical Systems Dmc GmbH | 09/21/2021SE |
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| K182834 | CS-series-FP with Optional ROI Accessory CA-100SJAA · Traditional | 03/29/2019SE |
| K171755 | CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOWB · Special | 02/09/2018SE |
| K121293 | Cs-Series-Fp with 3030+OPTIONJAA · Traditional | 07/26/2012SE |
| K100102 | Cs-Series-FpOWB · Traditional | 08/31/2010SE |
| K093572 | R650 Qdasm CollimatorIZW · Traditional | 02/03/2010SE |
| K070834 | Cs-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)OWB · Traditional | 05/18/2007SE |
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Questions and answers
When was Nyquist.IQ cleared by the FDA?
Nyquist.IQ (K212890) received a 510(k) decision of Substantially Equivalent on December 13, 2021, 94 days after the submission was received.
What is the product code of K212890?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.