Insight Essentials DRF Digital Imaging System
FDA 510(k) K191310 · Imaging Engineering, LLC
510(k) numberK191310
Submission
- Device name
- Insight Essentials DRF Digital Imaging System
- Applicant
- Imaging Engineering, LLC
Cape Coral, FL, US - Received
- May 15, 2019
- Decision date
- June 10, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAA
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|---|---|---|---|
| K253103 | Nexus DRF Digital X-ray Imaging SystemJAA · Traditional | Varex Imaging Corporation | 05/29/2026SE |
| K251650 | Insight Enhanced DRF (EN-1002-01)JAA · Traditional | Imaging Engineering, LLC | 09/16/2025SE |
| 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 |
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| 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 |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA · Special | Canon Medical Systems Corporation | 09/12/2023SE |
| K220871 | NautilusJAA · Special | Dornier Medtech America, Inc. | 04/18/2022SE |
| K212890 | Nyquist.IQJAA · Traditional | Omega Medical Imaging, LLC | 12/13/2021SE |
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Questions and answers
When was Insight Essentials DRF Digital Imaging System cleared by the FDA?
Insight Essentials DRF Digital Imaging System (K191310) received a 510(k) decision of Substantially Equivalent on June 10, 2019, 26 days after the submission was received.
What is the product code of K191310?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.