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CardioGraphe Spotlight

by Arineta, Ltd.

Ref 07290016484007

CardioGraphe Spotlight is a device classified as Class IIb in the EU and Class II in the US made by Arineta, Ltd., registered in EUDAMED on 9 Jun 2026 (Basic UDI-DI 7290016484SLG5) with CE/MDR certificate 3903104CE01 valid until 1 Mar 2031, cleared under FDA 510(k) K161066 on 10 Aug 2016 and listed in FDA GUDID since 1 Jan 2019 (UDI-DI 07290016484007), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

1 Mar 2031

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier DEKRA Certification B.V.

510(k) K161066

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3903104CE01 Date14 Jul 2026IssuedStatusActive expires 1 Mar 2031
United StatesGUDID listing GUDID Number07290016484007 UDI-DI Date1 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK161066 Date10 Aug 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 7290016484SLG5 registered 9 Jun 2026 Active· +1 more in the status table
  • FDA 510(k) K161066 decided 10 Aug 2016 Active
  • FDA GUDID UDI-DI 07290016484007 listed 1 Jan 2019 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3903104CE01 Active Amended

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    14 Jul 2026
    Expires
    1 Mar 2031
    Reason
    Other

Timeline

5 dated events

  1. Cleared FDA 510(k) K161066
  2. Listed FDA GUDID 07290016484007
  3. Registered EUDAMED 7290016484SLG5
  4. Certificate issued EUDAMED 3903104CE01
  5. Certificate expires EUDAMED 3903104CE01

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  • Withdrawn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
CardioGraphe
Generic name
Full-body CT system
Device name
SpotLight and CardioGraphe family of products
Model / reference
07290016484007 EUDAMED
Spotlight GUDID
Primary DI / UDI-DI
07290016484007
Basic UDI-DI
7290016484SLG5
Direct marketing DI
07290016484007
510(k) Number
FDA product code
JAK
EMDN code
Z11020301 CT/pet systems
GMDN term
Full-body CT system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1750
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
07290016484007
GUDID
Spotlight
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Full-body CT system

Similar devices in this category

Other devices filed under CT/PET SYSTEMS.

Other devices from Arineta, Ltd.

See all devices from Arineta, Ltd. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)