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Advantis Platform

FDA UDI

Class II (US FDA UDI)

by Advantis Medical Imaging Single Member P.C.

Identity

Trade Name
Advantis Platform FDA UDI
Generic Name
Radiology DICOM image processing application software FDA UDI
Device Name
Advantis Platform is a web-accessible medical viewing and post-processing software application. Advantis Platform offers comprehensive functionality for dynamic image analysis and visualization of brain and prostate MRI data which are acquired through DICOM-compliant imaging devices and modalities. FDA UDI
Model / Reference
4 FDA UDI
Description
Advantis Platform is a web-accessible medical viewing and post-processing software application. Advantis Platform offers comprehensive functionality for dynamic image analysis and visualization of brain and prostate MRI data which are acquired through DICOM-compliant imaging devices and modalities. FDA UDI

Identifiers

Primary DI / UDI-DI
05214002307035 FDA UDI
FDA Product Code
LLZ 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
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

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiology DICOM image processing application software

Advantis Platform by Advantis Medical Imaging Single Member P.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

Sources (1)

  • FDA UDI 24d4edc9-2481-4abc-a9a2-408e40fdf18a 34 fields · synced May 31, 2026