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ImagenPRO

FDA UDI

Class II (US FDA UDI)

by Cardiovascular Imaging Technologies L.l.c.

Identity

Trade Name
ImagenPRO FDA UDI
Generic Name
Radiology DICOM image processing application software FDA UDI
Device Name
ImagenPRO is a software application installed on desktop computers with allows physicians and healthcare professionals to inspect, reconstruct, and reorient myocardial perfusion PET images. The system processes perfusion and gated PET raw emission and transmission data to create 3D tomographic data. The user can select correction parameters, filter setting, range of reconstruction, and reorientation angels. FDA UDI
Model / Reference
2.2 FDA UDI
Description
ImagenPRO is a software application installed on desktop computers with allows physicians and healthcare professionals to inspect, reconstruct, and reorient myocardial perfusion PET images. The system processes perfusion and gated PET raw emission and transmission data to create 3D tomographic data. The user can select correction parameters, filter setting, range of reconstruction, and reorientation angels. FDA UDI

Identifiers

Primary DI / UDI-DI
00862611000318 FDA UDI
510(k) Number
K050366 FDA UDI
FDA Product Code
LLZ FDA UDI
KPS FDA UDI
GMDN Term
Radiology DICOM image processing application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
892.1200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiology DICOM image processing application software

ImagenPRO by Cardiovascular Imaging Technologies L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology DICOM image processing application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardiovascular Imaging Technologies L.l.c.

Sources (1)

  • FDA UDI ffe3ab4c-d0c0-4548-bc26-b5e6bb678b69 35 fields · synced Jun 6, 2026