FDA 510(k)

오토파antomограф™ OP 3D LX (PAN 3D); 오토파antomограф™ OP 3D LX (PAN CEPH 3D)

K-번호: K241249 · 2024-09-12

결정일2024-09-12

제품 코드OAS

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) is the device name listed in this FDA 510(k) record. The listed applicant is Palodex Group OY. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K241249. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)?

Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Palodex Group OY. The 510(k) number is K241249.

When did Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) receive FDA 510(k) clearance?

Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) received FDA 510(k) clearance on 2024-09-12, under 510(k) number K241249.

Who is the listed applicant for Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)?

The FDA 510(k) record lists Palodex Group OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)?

The FDA product code for Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) is OAS.

Palodex Group OY를 신청인으로 등재한 기타 기록

K230505오토판톤오그래프™ OP 3D LX K180947정형파antomограф OP 3D K173646FS 에르고 K163423오르تو판토그래프 OP300 K162799클리니뷰 K170813정형파antom그래프 OP 3D

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