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Tempus Pixel

by Arterys Inc.

Ref AMM7

Tempus Pixel (AMM7) is a medical device (EU MDR Class IIa; EMDN category radiology instruments - software accessories) made by Arterys Inc., cleared under FDA 510(k) K252539 on 3 Sep 2025 and registered in EUDAMED on 2 Apr 2025 (Basic UDI-DI ++B664MICAC6), active as of 23 Oct 2026.

Active European Union and United States

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252539↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK252539 Date3 Sep 2025IssuedStatusActive
European UnionCE/MDR EUDAMED Number++B664MICAC6 Basic UDI-DI +B664AMM71%UDI-DIDate2 Apr 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K252539 decided 3 Sep 2025 Active
  • EUDAMED Basic UDI-DI ++B664MICAC6 registered 2 Apr 2025 Active

Timeline

2 dated events

  1. Registered EUDAMED ++B664MICAC6
  2. Cleared FDA 510(k) K252539

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / reference
AMM7
Primary DI / UDI-DI
+B664AMM71%
Basic UDI-DI
++B664MICAC6
EMDN code
Z11030582 Radiology instruments - software accessories
Device class
Class IIa
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000001775
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES.

Other devices from Arterys Inc.

See all devices from Arterys Inc. →

Properties

Other properties (14, all answered No)