Data / Medical devices / China / Shenzhen Sanping Image Technology Co., Ltd.
Shenzhen Sanping Image Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Sanping Image Technology Co., Ltd. is registered with the FDA (registration 3021031769) in Shenzhen Guangdong, China. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 31, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3021031769
- Address
- Room 203, No. 634, Shajing Road, Buchong Community, Shajing Street, Bao'an District, Shenzhen Guangdong, China, 518104
- Owner or operator
- Shenzhen Sanping Image Technology Co., Ltd (10083057)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 21, 2021
- Registered through
- 2026
- Brand names listed
- Bronchoscope System, Flexible Ureterorenoscope system, Flexible video laryngoscope(SP-HJC), Tongue depressor, Video laryngoscope(SP-HJA)(SP-HJB)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Non-Rigid | CAL | 1 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 31, 2025 | K250917 | Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) | FGB | Substantially Equivalent | Shenzhen Sanping Image Technology Co., Ltd. | accessdata.fda.gov |
| March 14, 2025 | K242010 | Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1) | EOQ | Substantially Equivalent | Shenzhen Sanping Image Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Laryngoscope, Rigid
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Laryngoscope, Non-Rigid
- All makers of Ureteroscope And Accessories, Flexible/Rigid
- All makers of Depressor, Tongue, Non-Surgical
Updated October 31, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.