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MeVis AVM Contour 1.0

by MeVis Medical Solutions AG

MeVis AVM Contour 1.0 is a Class II device made by MeVis Medical Solutions AG, cleared under FDA 510(k) K260576 on 30 Jun 2026 and listed in FDA GUDID since 9 Jul 2026 (UDI-DI 04260483290305), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K260576

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04260483290305 UDI-DI Date9 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK260576 Date30 Jun 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K260576 decided 30 Jun 2026 Active
  • FDA GUDID UDI-DI 04260483290305 listed 9 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K260576
  2. Listed FDA GUDID 04260483290305

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MeVis AVM Contour
Generic name
Radiology DICOM image processing application software
Model / reference
1.0
Primary DI / UDI-DI
04260483290305
510(k) Number
FDA product code
LLZ
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from MeVis Medical Solutions AG

See all devices from MeVis Medical Solutions AG →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)