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Acteon Systeme Pspix Win Mac

by Sopro

Part of a family of 7 devices: see the family page

Ref S_702_0011Model S_702_0001

Acteon Systeme Pspix Win Mac (S_702_0011) is a device classified as Class I in the EU and Class II in the US made by Sopro, registered in EUDAMED on 26 Jan 2026 (Basic UDI-DI 801337602782D0001CP), cleared under FDA 510(k) K151053 on 31 Jul 2015 and listed in FDA GUDID since 19 Nov 2018 (UDI-DI 03760278260939), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K151053

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number801337602782D0001CP Basic UDI-DI 03760278260939UDI-DIDate26 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760278260939 UDI-DI Date19 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK151053 Date31 Jul 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 801337602782D0001CP registered 26 Jan 2026 Active
  • FDA 510(k) K151053 decided 31 Jul 2015 Active
  • FDA GUDID UDI-DI 03760278260939 listed 19 Nov 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K151053
  2. Listed FDA GUDID 03760278260939
  3. Registered EUDAMED 801337602782D0001CP

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
PSPIX2 EUDAMED
Acteon GUDID
Generic name
Dental computed radiography digital imaging scanner
Model / Ref / Catalog
S_702_0001, S_702_0011, SYSTEME PSPIX WIN MAC
Primary DI / UDI-DI
03760278260939
Basic UDI-DI
801337602782D0001CP
Direct marketing DI
03760278260434
510(k) Number
FDA product code
MUH
EMDN code
Z110601 Laser imaging scanner
GMDN term
Dental computed radiography digital imaging scanner
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.1800
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
S_702_0001
S_702_0011
GUDID
SYSTEME PSPIX WIN MAC
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental computed radiography digital imaging scanner

Cleared under the same submission (K151053)

Similar devices in this category

Other devices filed under LASER IMAGING SCANNER.

Other devices from Sopro

  • SOPIX2

    Class IIa

  • Sopix 2

    Class II

  • Sopix

    Class IIa

  • PSPIX2

    Class I

See all devices from Sopro →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)