FDA.reportPublic FDA data

ARTERYS INC.

Matched from indexed company URL: Arterys Inc.

FDA Registration(s)#

Registration, FEI, Name table
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 GUDID, Product, Phone table
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 key, Listing key, Premarket submission table
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 code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ42018-10-17
QIH12025-09-03

PMN#

GUDID#