WEBCEPH™
人工智能驱动的正畸和正颌骨在线平台
WEBCEPH™ is a FDA 510(k)-cleared and MFDS approved A.I. driven Online Orthodontic Diagnostic Software for dentists.
The Artificial Intelligence technologies of WEBCEPH™ are patented by the US and Korean Intellectual Property Office.
Regulatory Clearance
- FDA 510(k) Clearance
- MFDS Approval (Korea)
Certifications
- ISO 13485:2016
-
Medical Device Cybersecurity Verification
Verified under the Medical Device Cybersecurity Review Guidelines.
Testing verified by the Korea Internet & Security Agency (KISA).
Intellectual Property
Patented AI Technology
- KR Patent
- KR Patent
- KR Patent
- KR Patent
- US Patent
의료기기 정보 표시
디지털의료기기소프트웨어
품목명
치과영상치료계획소프트웨어
모델명
WebCeph
인증번호
제인 21-4431호
허가번호
D제7366호
제조업자
(주)어셈블써클
제조업자 주소
경기도 성남시 분당구 판교역로 240 411호 (삼평동, 삼환하이펙스A동)
제조업자 연락처
031-697-0433
Medical Device Information
Device Name
WebCeph
Manufacturer
AssembleCircle Corp.
Address
411-ho, 4F, 240 Pangyoyeok-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
UDI
Software Version
1.0.5
Date of Manufacture
02/27/2026
Instructions for Use
FDA 510(k)
K220903