Beijing East Whale Imaging Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Beijing East Whale Imaging Technology Co., Ltd.” (first 2013, latest 2017), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 82 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 175 |
| 2014 | 1 | 38 |
| 2015 | 1 | 139 |
| 2016 | 2 | 82 |
| 2017 | 1 | 28 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Beijing East Whale Imaging Technology Co., Ltd. took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 5 | 5 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
Review panels
- Radiology (6)
Most recent Beijing East Whale Imaging Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163429 | B6 | OXO | 2017-01-04 | 28 |
| K160984 | MultiScan G-Arm System | OXO | 2016-07-20 | 104 |
| K160343 | SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner | IYN | 2016-04-07 | 59 |
| K151280 | MultiScan G-Arm System | OXO | 2015-09-30 | 139 |
| K141672 | DIGIARC 100AU+ | OXO | 2014-07-31 | 38 |
| K131423 | G-ARM MULTISCAN SYSTEM | OXO | 2013-11-07 | 175 |
Recalls
openFDA lists no recalls under a recalling firm named Beijing East Whale Imaging Technology Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Beijing Choice Electronic Technololgy Co., Ltd. (29 510(k)s)
- Beijing Choice Electronic Technology Co., Ltd. (14 510(k)s)
- Beijing Adss Development Co., Ltd. (10 510(k)s)
- Beijing Biosis Healing Biolog Ical Technology Co., Ltd. (7 510(k)s)
- Beijing Nubway S&T Co., Ltd. (6 510(k)s)
- Beijing Sano Laser S&T Development Co.,Ltd (6 510(k)s)
- Beijing Zksk Technology Co., Ltd. (6 510(k)s)
- Beijing Honkon Technologies Co., Ltd. (5 510(k)s)
- Beijing Superlaser Technology Co., Ltd. (5 510(k)s)
- Beijing Demax Medical Technology Co.,Ltd (4 510(k)s)
- Beijing Fule Science & Technology Development Co., Ltd. (4 510(k)s)
- Beijing Globalipl Development Co., Ltd. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Beijing East Whale Imaging Technology Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Beijing East Whale Imaging Technology Co., Ltd.” (first 2013, latest 2017), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Beijing East Whale Imaging Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Beijing East Whale Imaging Technology Co., Ltd. is 82 days.
Which FDA product codes appear under Beijing East Whale Imaging Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile, 5); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 1).
Next steps
- See all 6 Beijing East Whale Imaging Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OXO, Beijing East Whale Imaging Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.