Skip to content

C-Qual™ MT400

by Medtec LLC

Part of a family of 36 devices: see the family page

Ref MT400Model Breast Positioning Devices

C-Qual™ MT400 is a device classified as Class I in the EU and Class II in the US made by Medtec LLC, registered in EUDAMED on 22 May 2026 (Basic UDI-DI 8414391OC0010R019Y), cleared under FDA 510(k) K974703 on 10 Mar 1998 and listed in FDA GUDID since 2 Aug 2017 (UDI-DI 00841439102640), active as of 22 Oct 2026.

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

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K974703

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8414391OC0010R019Y Basic UDI-DI 00841439102640UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841439102640 UDI-DI Date2 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK974703 Date10 Mar 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8414391OC0010R019Y registered 22 May 2026 Active
  • FDA 510(k) K974703 decided 10 Mar 1998 Active
  • FDA GUDID UDI-DI 00841439102640 listed 2 Aug 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K974703
  2. Listed FDA GUDID 00841439102640
  3. Registered EUDAMED 8414391OC0010R019Y

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  • Withdrawn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
C-Qual™
Generic name
Radiological breast positioner, non-wearable
Model / Ref / Catalog
MT400, Breast Positioning Devices
Primary DI / UDI-DI
00841439102640
Basic UDI-DI
8414391OC0010R019Y
510(k) Number
FDA product code
IYE
EMDN code
Z12011280 Patient positioning instruments - hardware accessories
GMDN term
Radiological breast positioner, non-wearable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Radiological breast positioner, non-wearable

Cleared under the same submission (K974703)

and 8 more cleared under K974703

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Medtec LLC

See all devices from Medtec LLC →

Properties

  • Reusable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)