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ECTphan™

FDA UDI

Class I (US FDA UDI)

by Providus Holdings, Inc.

Identity

Trade Name
ECTphan™ FDA UDI
Generic Name
Multi-modality diagnostic imaging phantom, test object FDA UDI
Device Name
3D Image Fusion Ramp Cube, The 3D Image Fusion Ramp Cube enables verification of registration for SPECT/CT and PET/CT fusion imaging FDA UDI
Model / Reference
SMR357 FDA UDI
Description
3D Image Fusion Ramp Cube, The 3D Image Fusion Ramp Cube enables verification of registration for SPECT/CT and PET/CT fusion imaging FDA UDI

Identifiers

Catalog Number
SMR357 FDA UDI
Primary DI / UDI-DI
00812266030659 FDA UDI
FDA Product Code
IXF FDA UDI
GMDN Term
Multi-modality diagnostic imaging phantom, test object FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1940 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multi-modality diagnostic imaging phantom, test object

ECTphan™ by Providus Holdings, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-modality diagnostic imaging phantom, test object.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Providus Holdings, Inc.

Sources (1)

  • FDA UDI 663c8c09-bbf0-48bc-ac81-c8854e7285f5 34 fields · synced May 29, 2026