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ScanX Duo Touch J1205

by Air Techniques, Inc.

Ref J1200

ScanX Duo Touch J1205 (J1200) is a medical device (EU MDR Class I; FDA Class II; FDA product code MUH, System, X-Ray, Extraoral Source, Digital; EMDN category various radiodiagnostic and interventional instruments – other) made by Air Techniques, Inc., registered in EUDAMED on 22 Apr 2026 (Basic UDI-DI ++D678J1200T6), cleared under FDA 510(k) K191623 on 21 Aug 2019 and listed in FDA GUDID since 21 Apr 2023 (UDI-DI +D678J12050), 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) K191623

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 Number++D678J1200T6 Basic UDI-DI +D678J12050UDI-DIDate22 Apr 2026RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number+D678J12050 UDI-DI Date21 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191623 Date21 Aug 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++D678J1200T6 registered 22 Apr 2026 Active
  • FDA 510(k) K191623 decided 21 Aug 2019 Active
  • FDA GUDID UDI-DI +D678J12050 listed 21 Apr 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K191623
  2. Listed FDA GUDID +D678J12050
  3. Registered EUDAMED ++D678J1200T6

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  • Withdrawn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
ScanX Duo Touch
Generic name
Dental computed radiography digital imaging scanner
Model / Ref / Catalog
J1200, J1205
Primary DI / UDI-DI
+D678J12050 EUDAMED
D678J12050 GUDID
Basic UDI-DI
++D678J1200T6
510(k) Number
FDA product code
MUH
EMDN code
Z11039099 Various radiodiagnostic and interventional instruments – other
GMDN term
Dental computed radiography digital imaging scanner
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.1800
EU registration type
Standard device
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
J1200
GUDID
J1205
Primary DI / UDI-DIEUDAMED
+D678J12050
GUDID
D678J12050
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +D678J12050; FDA GUDID lists D678J12050), so their flags are not compared. 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: Dental computed radiography digital imaging scanner

Cleared under the same submission (K191623)

Similar devices in this category

Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER.

Other devices from Air Techniques, Inc.

See all devices from Air Techniques, Inc. →

Properties

  • Serial number
Other properties (24, all answered No)