nordicMEDiVA
FDA 510(k) K243209 · Nordicneurolab AS
510(k) numberK243209
Submission
- Device name
- nordicMEDiVA
- Applicant
- Nordicneurolab AS
Bergen, NO - Received
- October 1, 2024
- Decision date
- October 22, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
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More from Avara Software
| 510(k) | Device | Decision |
|---|---|---|
| K251937 | nordicAudio (1.0)LNH · Traditional | 03/20/2026SE |
| K241608 | nordicMEDiVALLZ · Traditional | 06/28/2024SE |
| K232680 | fMRI Hardware SystemLNH · Traditional | 12/13/2023SE |
| K212720 | nordicDSCLLZ · Traditional | 03/03/2022SE |
| K191032 | fMRI Hardware SystemLNH · Traditional | 11/27/2019SE |
| K163324 | nordicBrainExLLZ · Traditional | 01/27/2017SE |
| K140956 | LCD MonitorLNH · Traditional | 08/07/2014SE |
| K133910 | NordicbrainexLLZ · Traditional | 04/04/2014SE |
| K123306 | Nordic TumorexLLZ · Traditional | 05/20/2013SE |
| K092253 | Modification to Fmri Hardware SystemLNH · Special | 10/08/2009SE |
Questions and answers
When was nordicMEDiVA cleared by the FDA?
nordicMEDiVA (K243209) received a 510(k) decision of Substantially Equivalent on October 22, 2024, 21 days after the submission was received.
What is the product code of K243209?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.