Portable X-ray System Model Ray98(P)

FDA 510(k) K231449 · Ningbo Runyes Medical Instrument Co., Ltd.

Substantially Equivalent

510(k) numberK231449

Submission

Device name
Portable X-ray System Model Ray98(P)
Applicant
Ningbo Runyes Medical Instrument Co., Ltd.
Ningbo, CN
Received
May 18, 2023
Decision date
July 13, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EHD – Unit, X-Ray, Extraoral With Timer
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Specialty
Dental

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More from Lucas Lifecare

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K252909Diagnostic X-Ray Equipment Model POCT22EHD · Traditional 02/03/2026SE

Questions and answers

When was Portable X-ray System Model Ray98(P) cleared by the FDA?

Portable X-ray System Model Ray98(P) (K231449) received a 510(k) decision of Substantially Equivalent on July 13, 2023, 56 days after the submission was received.

What is the product code of K231449?

The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.