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Acteon

FDA UDI

Class II (US FDA UDI)

by Sopro

Identity

Trade Name
ACTEON FDA UDI
Generic Name
Dental computed radiography digital imaging scanner FDA UDI
Device Name
"The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oral x-ray images stored in imaging plates (IPs) - also known as phosphor plates." FDA UDI
Model / Reference
SYSTEME PSPIX WIN MAC (Only) FDA UDI
Description
"The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oral x-ray images stored in imaging plates (IPs) - also known as phosphor plates." FDA UDI

Identifiers

Catalog Number
997090 FDA UDI
Primary DI / UDI-DI
03760278260434 FDA UDI
510(k) Number
K151053 FDA UDI
FDA Product Code
MUH FDA UDI
GMDN Term
Dental computed radiography digital imaging scanner FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.1800 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental computed radiography digital imaging scanner

Acteon by Sopro — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental computed radiography digital imaging scanner.

Cleared under the same submission

K151053 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sopro

Sources (1)

  • FDA UDI 8182ad4b-5e67-434a-8b0f-0d4c6fd8e1e9 36 fields · synced May 30, 2026