Data / Medical devices / China / Wisdom Technologies, Inc.
Wisdom Technologies, Inc.: FDA-registered device maker in Hefei Anhui, China, 2 510(k) clearances
Wisdom Technologies, Inc. is registered with the FDA (registration 3031194398) in Hefei Anhui, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 7, 2024. 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
- 3031194398
- Address
- 4th Floor, Building F2, Phase II, Innovation Industrial Park, Hefei Anhui, China, 230088
- Owner or operator
- Wisdom Technologies, Inc. (10090500)
- Roles
- Manufacturer
- First device listed
- April 5, 2024
- Registered through
- 2026
- Brand names listed
- ArcherQA, DeepContour
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Image Processing Software For Radiation Therapy | QKB | 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 |
|---|---|---|---|---|---|---|
| May 7, 2024 | K232928 | DeepContour (V1.0) | QKB | Substantially Equivalent | Wisdom Technologies., Inc. | accessdata.fda.gov |
| January 5, 2024 | K231273 | ArcherQA (V1.0) | IYE | Substantially Equivalent | Wisdom Technologies., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Radiological Image Processing Software For Radiation Therapy
- All makers of Accelerator, Linear, Medical
Updated May 7, 2024. 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.