Cleared Traditional

K150150 - 1717SGN / 1717SCN Digital Flat Panel X-ray Detector

K150150 is an FDA 510(k) clearance for 1717SGN / 1717SCN Digital Flat Panel X-..., manufactured by Rayence Co., Ltd.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K150150 · Rayence Co., Ltd. · Radiology device
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Mar 2015
Decision
63d
Days
Class 2
Risk

K150150 is an FDA 510(k) clearance for the 1717SGN / 1717SCN Digital Flat Panel X-ray Detector. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Rayence Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on March 27, 2015 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rayence Co., Ltd. devices

FDA 510(k) Submission Details - K150150

510(k) Number K150150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2015
Decision Date March 27, 2015
Days to Decision 63 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Mtechgroup
Dave Kim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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