Data / Medical devices / United States / Erad, Inc.
Erad, Inc.: FDA-registered device maker in Greenville, SC, United States, 2 510(k) clearances
Erad, Inc. is registered with the FDA (registration 2954766) in Greenville, SC, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated October 31, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2954766
- FEI number
- 3003150833
- Address
- 201 Brookfield Pkwy Ste 160, Greenville, SC, United States, 29607
- Owner or operator
- ERAD, INC. (9042966)
- Roles
- Manufacturer
- First device listed
- October 30, 2013
- Registered through
- 2026
- Brand names listed
- DeepHealth Viewer, PracticeBuilder 1-2-3, eRAD PACS, eRAD RIS/PACS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 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, 2024 | K241223 | eRAD PACS | LLZ | Substantially Equivalent | Erad, Inc. | accessdata.fda.gov |
| December 3, 2012 | K120995 | ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT | LLZ | Substantially Equivalent | Erad, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 31, 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.