Arterys Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000001775 FEI 3013306229
Arterys Inc. is a medical device manufacturer based in the United States, with 17 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II; EU Class IIa) as of 15 Nov 2026.
- Devices
- 17
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 9
- FDA 510(k) 7
- EUDAMED 1
- Device classes
- FDA Class II 16
- EU Class IIa 1
- Top EMDN categories
- Sites and related companies
- Emergo Europe B.V. authorised representative
- Identifiers
- EUDAMED SRN US-MF-000001775
- FDA FEI 3013306229
- DUNS 078466835
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
- Authorised rep.
- Emergo Europe B.V.NL
What Arterys Inc. makes
Arterys Inc. makes software for radiology DICOM image processing, including applications such as Tempus Pixel, Arterys MICA, and Arterys Cardio DL. These products are designed to process medical images. The company's portfolio includes various software applications for different medical specialties, such as cardiology and oncology.
The company's devices are classified as Class II and Class IIa, and are listed in registries such as Eudamed, FDA 510(k), and FDA UDI. Arterys Inc. is based in the US.
Catalogue
Search and filter all 17 devicesCompany details
- EUDAMED SRN
- US-MF-000001775
- FDA FEI number
- 3013306229
- DUNS number
- 078466835
- EUDAMED status
- Active
- EUDAMED registered name
- Arterys Inc.
- EUDAMED abbreviated name
- Arterys
- Registered address
- 600, West Chicago Avenue, 60654, Chicago, United States
- Website
- tempus.com
- support@tempus.com
- Phone
- 800-739-4137
- PRRC contact
- Julia Yeh
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 14 Apr 2031
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 730904 Active
Quality management system EU MDR
- Issued
- 20 Mar 2026
- Expires
- 14 Apr 2031
- Valid from
- 15 Apr 2026
Frequently asked questions
How many devices does Arterys Inc. have in the registry?
The registry currently lists 17 devices for Arterys Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Arterys Inc.'s devices?
Among its 17 most recently registered devices, Arterys Inc. has devices listed in EUDAMED (1 device), FDA 510(k) (7 devices) and FDA GUDID (9 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Arterys Inc.'s devices fall under?
Among its 17 most recently registered devices, the classes recorded for Arterys Inc.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Arterys Inc.?
EUDAMED lists 1 certificate for Arterys Inc. (quality management system) under MDR. The most recent was issued on 20 Mar 2026.
What are the newest devices from Arterys Inc. in the registry?
The most recently registered devices listed for Arterys Inc. include Arterys Oncology DL AOM4, Arterys Cardio DL CVM2, Arterys MICA AMM7 and Tempus Pixel AMM7.