FDA 510(k) clearance · back to tracker

Imaging system of positron emission and X-ray computed tomography (DigitMI 930)

Raysolution Healthcare Co., Ltd. cleared K241266 on 2025-01-27, decision: substantially equivalent

K-number

K241266

Sponsor

Raysolution Healthcare Co., Ltd.

Device

Imaging system of positron emission and X-ray computed tomography (DigitMI 930)

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-01-27

Product code

KPS

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1200

Official FDA record

Open K241266on 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.