FDA.reportPublic FDA data

Therapixel

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30167591153016759115Therapixel Inc.1Y2026-01-011700 W Irving Park Rd ST. 209A Chicago IL US 60613

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
B885MAML0MammoScreen - Radiological computer assisted detection and diagnosis software+33625467635support@therapixel.com
B885MAML2US0MammoScreen - Radiological computer assisted detection and diagnosis software+33625467635support@therapixel.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2608771960959588K243685MammoScreen BDQIH2025-08-22
2608771823638008K243679MammoScreen® (4)QDQ2025-07-03
2608771769929709K241561MammoScreen BDQIH2024-10-02
2608771384170897K240301MammoScreen® (3)QDQ2024-08-01
2608771391159852K211541MammoScreen 2.0QDQ2021-11-26
2608771667867800

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QDQ32025-07-03
QIH22025-08-22

PMN#

GUDID#