HeartSee Cardiac PET Processing Software 001771

GUDID 30815112021543

Image segmentation application software

Primary Device ID	30815112021543
NIH Device Record Key	0a50949c-7302-40e7-a636-28f907714231
Commercial Distribution Status	In Commercial Distribution
Brand Name	HeartSee Cardiac PET Processing Software
Version Model Number	4
Catalog Number	001771
Company DUNS	849234661
Company Name	Bracco Diagnostics Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	30815112021543 [Primary]

KPS	System, Tomography, Computed, Emission

Steralize Prior To Use	false
Device Is Sterile	false

30815112020584	Cardiac PET Processing Software
30815112021543	Cardiac PET Processing Software