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Tempus Pixel
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref AMM7510(k) K252539
by Arterys Inc.
Identity
- Trade Name
- Tempus Pixel EUDAMED
- Device Name
- Tempus Pixel EUDAMED
- Model / Reference
- AMM7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B664AMM71% EUDAMED
- Basic UDI-DI
- ++B664MICAC6 EUDAMED
- EMDN Code
- Z11030582 RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Tempus Pixel by Arterys Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252539 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++B664MICAC6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Arterys Inc.
- EUDAMED SRN
- US-MF-000001775
- FDA Applicant
- Arterys, Inc.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED bb17612a-8ba8-4c24-a891-97c51f358ac5 85 fields · synced Jun 18, 2026
- EUDAMED b40407df-9113-4cce-9791-fd989227cdd9 61 fields · synced Jun 18, 2026
- FDA 510(k) K252539 1 fields · synced May 18, 2026