FDA 510(k) clearance · back to tracker

SC1 Handheld Ultrasound Imaging system (Model: SC1)

Fcu Co., Ltd. cleared K233579 on 2024-06-26, decision: substantially equivalent

K-number

K233579

Sponsor

Fcu Co., Ltd.

Device

SC1 Handheld Ultrasound Imaging system (Model: SC1)

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-06-26

Product code

IYO

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1560

Official FDA record

Open K233579on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.