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Caas Mrv 3.0

by Pie Medical Imaging B.V.

Caas Mrv 3.0 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Pie Medical Imaging B.V., cleared under FDA 510(k) K060941 on 19 Apr 2006 and listed in FDA GUDID since 27 Sep 2016 (UDI-DI 08056304451163), 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) K060941

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 Number08056304451163 UDI-DI Date27 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK060941 Date19 Apr 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K060941 decided 19 Apr 2006 Active
  • FDA GUDID UDI-DI 08056304451163 listed 27 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K060941
  2. Listed FDA GUDID 08056304451163

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Caas Mrv
Generic name
Radiology DICOM image processing application software
Model / reference
3.0
Primary DI / UDI-DI
08056304451163
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 in this category

Other devices filed under Radiology DICOM image processing application software.

Other devices from Pie Medical Imaging B.V.

See all devices from Pie Medical Imaging B.V. →

Properties

  • Prescription use
  • Manufacturing date
Other properties (13, all answered No)