FDA 510(k) Premarket Notification K150150: 1717SGN / 1717SCN Digital Flat Panel X-ray Detector

Submission Details & Decision

Normalized public record details for 510(k) notification K150150.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K150150

Applicant / Sponsor

Rayence Co., Ltd.

Device Name

1717SGN / 1717SCN Digital Flat Panel X-ray Detector

Product Code

MQB

Decision Date

2015-03-27

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Traditional

Third Party Flag

Date Received

2015-01-23

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