Adora DRFi (04550010)
FDA 510(k) K242948 · Nrt X-Ray A/S
510(k) numberK242948
Submission
- Device name
- Adora DRFi (04550010)
- Applicant
- Nrt X-Ray A/S
Hasselager, DK - Received
- September 25, 2024
- Decision date
- December 23, 2024
- 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 |
| 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 |
| 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 |
| K212837 | ProxiDiagnost N90JAA · Special | Philips Medical Systems Dmc GmbH | 09/21/2021SE |
More from Philips Medical Systems Dmc GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K173631 | Intelli-COWB · Traditional | 07/11/2018SE |
Questions and answers
When was Adora DRFi (04550010) cleared by the FDA?
Adora DRFi (04550010) (K242948) received a 510(k) decision of Substantially Equivalent on December 23, 2024, 89 days after the submission was received.
What is the product code of K242948?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.