FDA.reportPublic FDA data

SCIMAGE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29525963000206530SCIMAGE, INC.1Y2026-01-014916 EL CAMINO REAL, SUITE 200 LOS ALTOS CA US 94022

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
00861917000305PicomEnterprise - 3.x866-724-6243tech_support@scimage.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
524201856527131K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPMWI2017-09-08
524201013450935K073169SCIMAGE PICOMENTERPRISELLZ2008-01-09
524201735709226K003484NETRA WORKSTATION AND NETRAMD SOFTWARELLZ2001-01-19
524201619827171

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ42008-01-09
MWI12017-09-08

PMN#

GUDID#