Cleared Traditional

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)

K240040 · VATECH Co., Ltd. · Radiology
Oct 2024
Decision
294d
Days
Class 2
Risk

About This 510(k) Submission

K240040 is an FDA 510(k) clearance for the 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), a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by VATECH Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on October 25, 2024, 294 days after receiving the submission on January 5, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K240040 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 2024
Decision Date October 25, 2024
Days to Decision 294 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800