Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Beijing East Whale Imaging Technology Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
175 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163429 | B6 | Beijing East Whale Imaging Technology Co., Ltd. | 2017-01-04 | 28 | 0 |
| K160984 | MultiScan G-Arm System | Beijing East Whale Imaging Technology Co., Ltd. | 2016-07-20 | 104 | 0 |
| K160343 | SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic | Beijing East Whale Imaging Technology Co., Ltd. | 2016-04-07 | 59 | 0 |
| K151280 | MultiScan G-Arm System | Beijing East Whale Imaging Technology Co., Ltd. | 2015-09-30 | 139 | 0 |
| K141672 | DIGIARC 100AU+ | Beijing East Whale Imaging Technology Co., Ltd. | 2014-07-31 | 38 | 0 |
| K131423 | G-ARM MULTISCAN SYSTEM | Beijing East Whale Imaging Technology Co., Ltd. | 2013-11-07 | 175 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda