Shanghai Chenguang Medical Technologies Co, Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Shanghai Chenguang Medical Technologies Co, Ltd.” (first 2007, latest 2011), across 1 product code in 1 review panel. Median 510(k) review time under this name: 17 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 8 | 8 |
Review panels
- Radiology (8)
Most recent Shanghai Chenguang Medical Technologies Co, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112002 | CAROTID COIL | MOS | 2011-11-18 | 128 |
| K101949 | PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 | MOS | 2010-07-28 | 16 |
| K101858 | PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 | MOS | 2010-07-14 | 12 |
| K092962 | CAROTID COIL 5000004901 | MOS | 2009-10-09 | 14 |
| K081340 | PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201 | MOS | 2008-06-18 | 36 |
| K081322 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL | MOS | 2008-06-18 | 37 |
| K071847 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL | MOS | 2007-07-23 | 18 |
| K071882 | MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH, | MOS | 2007-07-18 | 9 |
Recalls
openFDA lists no recalls under a recalling firm named Shanghai Chenguang Medical Technologies 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Shanghai Chenguang Medical Technologies Co, Ltd. (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
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.
- Shanghai United Imaging Healthcare Co., Ltd. (85 510(k)s)
- Shanghai AnQing Medical Instrument Co., Ltd. (14 510(k)s)
- Shanghai Antares Industries, Inc. (14 510(k)s)
- Shanghai Apolo Medical Technology Co., Ltd. (14 510(k)s)
- Shanghai Palomar Mountain Industries, Inc. (12 510(k)s)
- Shanghai Sanyou Medical Co, Ltd. (9 510(k)s)
- Shanghai Motex Healthcare Co., Ltd. (8 510(k)s)
- Shanghai Poseidon Plastic Products Co., Ltd. (8 510(k)s)
- Shanghai Champion Plastic Products Co., Ltd. (6 510(k)s)
- Shanghai PT Plastics Enterprise Company, Ltd. (6 510(k)s)
- Shanghai SeeGen Photoelectric Technology Co., Ltd. (6 510(k)s)
- Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shanghai Chenguang Medical Technologies Co, Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Shanghai Chenguang Medical Technologies Co, Ltd.” (first 2007, latest 2011), across 1 product code 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 Shanghai Chenguang Medical Technologies Co, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shanghai Chenguang Medical Technologies Co, Ltd. is 17 days.
Which FDA product codes appear under Shanghai Chenguang Medical Technologies Co, Ltd.?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 8).
Next steps
- See all 8 Shanghai Chenguang Medical Technologies Co, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MOS, Shanghai Chenguang Medical Technologies 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.