Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shanghai Chenguang Medical Technologies Co, Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
18 daysmedian FDA review time
128 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112002 | CAROTID COIL | Shanghai Chenguang Medical Technologies Co, Ltd. | 2011-11-18 | 128 | 0 |
| K101949 | PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 | Shanghai Chenguang Medical Technologies Co, Ltd. | 2010-07-28 | 16 | 0 |
| K101858 | PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 | Shanghai Chenguang Medical Technologies Co, Ltd. | 2010-07-14 | 12 | 0 |
| K092962 | CAROTID COIL 5000004901 | Shanghai Chenguang Medical Technologies Co, Ltd. | 2009-10-09 | 14 | 0 |
| K081322 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDI | Shanghai Chenguang Medical Technologies Co, Ltd. | 2008-06-18 | 37 | 0 |
| K081340 | PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201 | Shanghai Chenguang Medical Technologies Co, Ltd. | 2008-06-18 | 36 | 0 |
| K071847 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP | Shanghai Chenguang Medical Technologies Co, Ltd. | 2007-07-23 | 18 | 0 |
| K071882 | MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH, | Shanghai Chenguang Medical Technologies Co, Ltd. | 2007-07-18 | 9 | 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