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ScanX Swift View G8500

by Durr Dental AG

ScanX Swift View G8500 is a Class II device made by Durr Dental AG, cleared under FDA 510(k) K170733 on 1 May 2017 and listed in FDA GUDID since 6 Jul 2018 (UDI-DI E247G85000), active as of 22 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 22 Oct 2026

Documents

510(k) K170733

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberE247G85000 UDI-DI Date6 Jul 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170733 Date1 May 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170733 decided 1 May 2017 Active
  • FDA GUDID UDI-DI E247G85000 listed 6 Jul 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170733
  2. Listed FDA GUDID E247G85000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ScanX Swift View
Generic name
Radiography digital imaging scanner
Model / reference
G8500
Primary DI / UDI-DI
E247G85000
510(k) Number
FDA product code
MUH
GMDN term
Radiography digital imaging scanner
Device class
Class II
Regulation number
872.1800
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code MUH (System, X-Ray, Extraoral Source, Digital).

Other devices from Durr Dental AG

See all devices from Durr Dental AG →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)