Eva Select 9992412105

Eva Select 9992412105 is a Class II device made by ImageWorks, cleared under FDA 510(k) K123419 on 27 Dec 2012 and listed in FDA GUDID since 2 Dec 2016 (UDI-DI D83399924121050), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD83399924121050 UDI-DI	Date2 Dec 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK123419	Date27 Dec 2012Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K123419

Across registries

2 registries list this device

FDA 510(k) K123419 decided 27 Dec 2012 Active
FDA GUDID UDI-DI D83399924121050 listed 2 Dec 2016 Listed

Timeline

2 dated events

27 Dec 2012 Cleared FDA 510(k) K123419
2 Dec 2016 Listed FDA GUDID D83399924121050

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Eva Select
Generic name: General-purpose dental x-ray system application software
Model / Ref / Catalog: 9992412105

Primary DI / UDI-DI: D83399924121050
510(k) Number: K123419
FDA product code: MUH
GMDN term: General-purpose dental x-ray system application software

Device class: Class II
Regulation number: 872.1800
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under General-purpose dental x-ray system application software.

Other devices from ImageWorks

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Properties

Serial number
Manufacturing date

Other properties (13, all answered No)