MEDIMAGE, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1833124	1833124	MEDIMAGE, INC.	1	N	2026-01-01	333 Jackson Plz ANN ARBOR MI US 48103

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 GUDID	Product	Phone	Email
00861333000309	DELTAmanager - DELTAmanager is a software package that provides display, review, and communications for Nuclear Medicine, Molecular Imaging, and PET/CT images. DELTAmanager may be used for remote reading on a stand alone workstation or as a plug-in on a PACS workstation.	734-665-5400	sales@medimage.com

medimage.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
33529	1787639965	K946334	GALEN	KPS	1995-03-23
33529	2028328510	K933321	DELTAMANAGER	KPS	1993-11-03
33529	1951415727	K922303	M-LINK	KPS	1992-12-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KPS	3	1995-03-23

PMN#

QSM Software, QSMetric
2021-07-22
Medimagemetric LLC
GALEN
1995-03-23
MEDIMAGE, INC.
DELTAMANAGER
1993-11-03
MEDIMAGE, INC.
M-LINK
1992-12-11
MEDIMAGE, INC.

GUDID#

DELTAmanager - DELTAmanager is a software package that provides display, review, and communications for Nuclear Medicine, Molecular Imaging, and PET/CT images. DELTAmanager may be used for remote reading on a stand alone workstation or as a plug-in on a PACS workstation.
MEDIMAGE, INC.
2016-09-14