FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tempus Pixel
K Number: K252539
·
Decision Sep 3, 2025
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
8
Review Days
22
Basic Information
- Device Name
- Tempus Pixel
- K Number
- K252539
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arterys, Inc.
- Date Received
- August 12, 2025
- Decision Date
- September 3, 2025
- 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 Arterys, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K203744 | Arterys MICA | Mar 14, 2022 | Substantially Equivalent |
| K192437 | Arterys MICA | Mar 25, 2020 | Substantially Equivalent |
| K182034 | Arterys MICA | Oct 17, 2018 | Substantially Equivalent |
| K173542 | Arterys Oncology DL | Jan 25, 2018 | Substantially Equivalent |
| K171544 | Arterys Viewer | Jul 18, 2017 | Substantially Equivalent |
| K163253 | Arterys Cardio DL | Jan 5, 2017 | Substantially Equivalent |
| K162513 | Arterys Software v2.0 | Oct 28, 2016 | Substantially Equivalent |