FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Affinity
K Number: K193152
·
Decision Feb 14, 2020
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
16
Review Days
93
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Basic Information
- Device Name
- Affinity
- K Number
- K193152
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hermes Medical Solutions AB
- Date Received
- November 13, 2019
- Decision Date
- February 14, 2020
- Product Code
- KPS
- 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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | FDA class 2 | Radiology |
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Other Clearances by Hermes Medical Solutions AB
| K Number | Device Name | ||
|---|---|---|---|
| K252477 | Hybrid Viewer (00859873006240) | Sep 9, 2025 | Substantially Equivalent |
| K243919 | Voxel Dosimetry (00859873006226) | Jul 30, 2025 | Substantially Equivalent |
| K241364 | Hybrid Viewer (00859873006189) | Nov 8, 2024 | Substantially Equivalent |
| K202882 | Affinity | Dec 23, 2020 | Substantially Equivalent |
| K191216 | Voxel Dosimetry v1.0 | Oct 17, 2019 | Substantially Equivalent |
| K181468 | Hybrid3D | Oct 25, 2018 | Substantially Equivalent |
| K171719 | Hybrid3D | Nov 21, 2017 | Substantially Equivalent |
| K171681 | Hermes Medical Imaging Suite v5.7 | Nov 21, 2017 | Substantially Equivalent |
| K163687 | OLINDA EXM | Jul 19, 2017 | Substantially Equivalent |
| K163394 | Hybrid3D | May 22, 2017 | Substantially Equivalent |