FDA applicant
Beijing East Whale Imaging Technology Co., Ltd.
FDA records 6 decisions for Beijing East Whale Imaging Technology Co., Ltd. (Beijing, CN) from 2013 to 2017: 6 510(k) clearances. Most are in product codes OXO (Image-Intensified Fluoroscopic X-Ray System…) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 57 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Beijing East Whale Imaging Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
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