FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Neurophet AQUA (V3.1)
K Number: K242215
·
Decision Oct 25, 2024
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
6
Review Days
88
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Basic Information
- Device Name
- Neurophet AQUA (V3.1)
- K Number
- K242215
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurophet., Inc.
- Date Received
- July 29, 2024
- Decision Date
- October 25, 2024
- Product Code
- QIH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
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Other Clearances by Neurophet., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261273 | Neurophet AQUA | May 15, 2026 | Substantially Equivalent |
| K252563 | Neurophet SCALE PET | May 15, 2026 | Substantially Equivalent |
| K252496 | Neurophet AQUA AD Plus | Jan 29, 2026 | Substantially Equivalent |
| K220437 | Neurophet AQUA | May 10, 2023 | Substantially Equivalent |
| K221405 | Neurophet SCALE PET | Aug 5, 2022 | Substantially Equivalent |