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Smart-C Monitor Cart

by Turner Imaging Systems, Inc.

Ref 902-00004-002Model 902-00004510(k) K190024

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

CE MDD 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190024↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00850003909028 Basic UDI-DI 00850003909028UDI-DIDate17 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00850003909028 UDI-DI Date16 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Abbreviated NumberK190024 Date27 Sep 2019ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Smart-C Monitor Cart EUDAMED
Smart-C GUDID
Generic Name
Mobile general-purpose fluoroscopic x-ray system, digital
Model / Reference
902-00004 EUDAMED
902-00004-002 EUDAMED
Monitor Cart for Smart-C GUDID
Primary DI / UDI-DI
00850003909028
Basic UDI-DI
B-00850003909028
510(k) Number
FDA Product Code
OXO, JAA
EMDN Code
V0880 Medical support equipment - accessories
GMDN Term
Mobile general-purpose fluoroscopic x-ray system, digital
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.1650
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
902-00004
902-00004-002
GUDID
Monitor Cart for Smart-C
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000043549
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Turner Imaging Systems, Inc.

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No