Data / Medical devices / United States / Proscia, Inc.
Proscia, Inc.: FDA-registered device maker in Philadelphia, PA, United States, 1 510(k) clearance
Proscia, Inc. is registered with the FDA (registration 3025774973) in Philadelphia, PA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 8, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025774973
- Address
- 1700 Market St Fl 24, Philadelphia, PA, United States, 19103
- Owner or operator
- Proscia, Inc. (10060244)
- Roles
- Manufacturer
- First device listed
- March 27, 2024
- Registered through
- 2026
- Brand names listed
- Concentriq AP-Dx, Concentriq AP-Dx-US, Concentriq Dx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Digital Pathology Image Viewing And Management Software | QKQ | 2 | Manufacturer | accessdata.fda.gov |
| Whole Slide Imaging System | PSY | 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 |
|---|---|---|---|---|---|---|
| February 8, 2024 | K230839 | Concentriq Dx | PSY | Substantially Equivalent | Proscia, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Whole Slide Imaging System
- All makers of Digital Pathology Image Viewing And Management Software
Updated February 8, 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.