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Headrest MTSILVER2E

by Medtec LLC

Part of a family of 108 devices: see the family page

Ref MTSILVER2EModel Head, Neck, and Shoulder Devices

Headrest MTSILVER2E 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 8414391OC0005R01AQ), cleared under FDA 510(k) K080072 on 4 Jun 2008 (1 earlier submission) and listed in FDA GUDID since 2 Aug 2017 (UDI-DI 00841439107720), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

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 ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K080072

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8414391OC0005R01AQ Basic UDI-DI 00841439107720UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841439107720 UDI-DI Date2 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK080072 Date4 Jun 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8414391OC0005R01AQ registered 22 May 2026 Active
  • FDA 510(k) K080072 decided 4 Jun 2008 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00841439107720 listed 2 Aug 2017 Listed

Recalls

2 recalls · FDA

    • Terminated Z-2243-2020 FDA Class II initiated 12 May 2020

    Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk associated with the disengagement of the extension could be a patient fall if the patient is not supported by clinical staff.

    • Terminated Z-0124-2010 FDA Unclassified (pre-2012) initiated 31 Aug 2009

    Some of the packages contain the incorrect mask style.

Timeline

6 dated events

  1. Cleared FDA 510(k) K933227
  2. Cleared FDA 510(k) K080072
  3. Recall initiated FDA recalls Z-0124-2010
  4. Listed FDA GUDID 00841439107720
  5. Recall initiated FDA recalls Z-2243-2020
  6. Registered EUDAMED 8414391OC0005R01AQ

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
Headrest
Generic name
Radiological headrest
Model / Ref / Catalog
MTSILVER2E, Head, Neck, and Shoulder Devices
Primary DI / UDI-DI
00841439107720
Basic UDI-DI
8414391OC0005R01AQ
510(k) Number
FDA product code
IYE
EMDN code
Z12011299 Patient positioning instruments – other
GMDN term
Radiological headrest
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
MRI safety
MR Safe
Size
Length — 11 Inch
Width — 6.6 Inch

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 headrest

Cleared under the same submission (K080072)

and 8 more cleared under K080072

Cleared under the same submission (K933227)

and 8 more cleared under K933227

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS – OTHER.

Other devices from Medtec LLC

See all devices from Medtec LLC →

Properties

  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)