FDA 510(k)

간 지방-ultrasound 정량 시스템, The FattaLab (FL-CC M1, FL-CC M1_Pro)

K-번호: K253221 · 2026-02-06

신청자Eieling Technology (Shenzhen) Limited

결정일2026-02-06

제품 코드IYO

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

결정대체적으로 동일

기기 요약

Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) is the device name listed in this FDA 510(k) record. The listed applicant is Eieling Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K253221. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)?

Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is Eieling Technology (Shenzhen) Limited. The 510(k) number is K253221.

When did Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) receive FDA 510(k) clearance?

Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) received FDA 510(k) clearance on 2026-02-06, under 510(k) number K253221.

Who is the listed applicant for Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)?

The FDA 510(k) record lists Eieling Technology (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)?

The FDA product code for Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) is IYO.

Eieling Technology (Shenzhen) Limited를 신청인으로 등재한 기타 기록

K242496포터블 간 엘라스토그래피 초음파 진단 시스템 (Liverscan C)

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