Data / Medical devices / United States / Apryse Software Corp.
Apryse Software Corp.: FDA-registered device maker in Charlotte, NC, United States, 3 510(k) clearances
Apryse Software Corp. is registered with the FDA (registration 3004915908) in Charlotte, NC, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 25, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004915908
- Address
- 1927 S Tryon St Ste 200, Charlotte, NC, United States, 28203
- Owner or operator
- Apryse Software Corp (9067642)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 26, 2004
- Registered through
- 2026
- Brand names listed
- MiPACS Dental Enterprise Viewer, MiPACS HTML5 Web Viewer, MiPACS Storage Server, MiPACS V5
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Digital Image Storage, Radiological | LMB | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| June 25, 2026 | K260231 | MiPACS V5 (1.0.0) | LLZ | Substantially Equivalent | Apryse Software Corp | accessdata.fda.gov |
| November 12, 2021 | K212984 | MiPACS HTML5 Web Viewer | LLZ | Substantially Equivalent | Lead Technologies, Inc. | accessdata.fda.gov |
| February 6, 2002 | K012439 | DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM | LLZ | Substantially Equivalent | Radco Data AB | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Device, Digital Image Storage, Radiological
Updated June 25, 2026. 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.