OrthoVision v2.1

by Ewoosoft Co., Ltd.

OrthoVision v2.1 is a Class II device made by Ewoosoft Co., Ltd., cleared under FDA 510(k) K173094 on 26 Oct 2017 and listed in FDA GUDID since 15 Dec 2020 (UDI-DI 08800019700081), active as of 23 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 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08800019700081 UDI-DI	Date15 Dec 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK173094	Date26 Oct 2017Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08800019700081
FDA 510(k) database 510(k) number K173094

Across registries

2 registries list this device

FDA 510(k) K173094 decided 26 Oct 2017 Active
FDA GUDID UDI-DI 08800019700081 listed 15 Dec 2020 Listed

Timeline

2 dated events

26 Oct 2017 Cleared FDA 510(k) K173094
15 Dec 2020 Listed FDA GUDID 08800019700081

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: OrthoVision
Generic name: General-purpose dental x-ray system application software
Model / reference: v2.1

Primary DI / UDI-DI: 08800019700081
510(k) Number: K173094
FDA product code: LLZ
GMDN term: General-purpose dental x-ray system application software

Device class: Class II
Regulation number: 892.2050
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number
Manufacturing date

Other properties (12, all answered No)