FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇴 Norway
nordicMEDiVA
K Number: K241608
·
Decision Jun 28, 2024
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
7
Review Days
24
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Basic Information
- Device Name
- nordicMEDiVA
- K Number
- K241608
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nordicneurolab AS
- Date Received
- June 4, 2024
- Decision Date
- June 28, 2024
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by Nordicneurolab AS
| K Number | Device Name | ||
|---|---|---|---|
| K251937 | nordicAudio (1.0) | Mar 20, 2026 | Substantially Equivalent |
| K243209 | nordicMEDiVA | Oct 22, 2024 | Substantially Equivalent |
| K232680 | fMRI Hardware System | Dec 13, 2023 | Substantially Equivalent |
| K212720 | nordicDSC | Mar 3, 2022 | Substantially Equivalent |
| K191032 | fMRI Hardware System | Nov 27, 2019 | Substantially Equivalent |
| K163324 | nordicBrainEx | Jan 27, 2017 | Substantially Equivalent |