VistaPano S Ceph 2.0 (VistaPano S Ceph) +3 more— 510(k) K240040

Name: FDA 510(k) clearance K240040
Creator: U.S. Food and Drug Administration
Published: 2024-10-25

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K240040 for VistaPano S Ceph 2.0 (VistaPano S Ceph) +3 more, Substantially Equivalent on 2024-10-25. Applicant: VATECH Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)
Applicant: VATECH Co., Ltd.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2024-01-05
Decision date: 2024-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.