Dexin Medical Imaging Technology Co., Ltd. FDA Record
Dexin Medical Imaging Technology Co., Ltd. has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Dexin Medical Imaging Technology Co., Ltd." is on file.
- Latest 510(k)
- Sep 2, 2015
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K143586 | FACT Medical Imaging Sysytem | Sep 2, 2015 |
Dexin Medical Imaging Technology Co., Ltd. and the FDA: common questions
Has Dexin Medical Imaging Technology Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Dexin Medical Imaging Technology Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Dexin Medical Imaging Technology Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Dexin Medical Imaging Technology Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
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