FDA.report

ARTERYS INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30133062293013306229ARTERYS INC.1N2026-01-01600 W Chicago Ave Ste 510 Chicago IL US 60654

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
08624310003104Arterys Cardio DL - CVM2800-739-4137support@tempus.com
08624310003203Arterys Viewer - AVM3800-739-4137support@tempus.com
B664AMM50Arterys MICA - AMM5800-739-4137support@tempus.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2008521950310147K252539Tempus PixelQIH2025-09-03
2008521584094799K182034Arterys MICALLZ2018-10-17
2008521600825560K173542Arterys Oncology DLLLZ2018-01-25
2008521090393515K171544Arterys ViewerLLZ2017-07-18
2008521821620698K163253Arterys Cardio DLLLZ2017-01-05

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
LLZ42018-10-17
QIH12025-09-03

PMN

GUDID