Cleared Traditional

K163429 - B6

K163429 is an FDA 510(k) clearance for B6, manufactured by Beijing East Whale Imaging Technology Co., Ltd.. The device is a Class 2 Radiology device with product code OXO cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K163429 · Beijing East Whale Imaging Technology Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
28d
Days
Class 2
Risk

K163429 is an FDA 510(k) clearance for the B6. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Beijing East Whale Imaging Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on January 4, 2017 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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.

FDA 510(k) Submission Details - K163429

510(k) Number K163429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2016
Decision Date January 04, 2017
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OXO Device Classification - Class 2, Special Controls

Product Code OXO Image-intensified Fluoroscopic X-ray System, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Fluoroscopy Of The Human Body.
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 Peers - OXO Image-intensified Fluoroscopic X-ray System, Mobile

All 74
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K163429.
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