← Back to catalogue

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
ECTphan™ Line Source Phantom, 20cm tank with 3 SMR352, line sources, and cantilever case mounting system. FDA UDI
Model / Reference
SMR355 FDA UDI
Description
ECTphan™ Line Source Phantom, 20cm tank with 3 SMR352, line sources, and cantilever case mounting system. FDA UDI

Identifiers

Catalog Number
SMR355 FDA UDI
Primary DI / UDI-DI
00812266030635 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Providus Holdings, Inc.

Sources (1)

  • FDA UDI 2457582e-af17-46e7-88b8-55b80f258b10 34 fields · synced Jun 1, 2026