Cleared Traditional

Portable X-ray System Model Ray98(P)

K231449 · Ningbo Runyes Medical Instrument Co., Ltd. · Radiology

Jul 2023

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K231449 is an FDA 510(k) clearance for the Portable X-ray System Model Ray98(P), a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Ningbo Runyes Medical Instrument Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on July 13, 2023, 56 days after receiving the submission on May 18, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K231449 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 2023
Decision Date	July 13, 2023
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF