# Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden

**Predicate Speed & CAPA Advisory Opportunity Score:** 41/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261788 |
| Device | Eden PACS |
| Applicant | Higia., Inc. d/b/a Eden |
| Specialty / panel | Radiology |
| Product code | LLZ |
| Device class | 2 |
| Clearance type | Abbreviated |
| Decision | Substantially Equivalent |
| Received | 2026-05-29 |
| Decision date | 2026-10-21 |
| Review time (days) | 145 |
| Third-party review | No |
| Applicant location | Wilmington, DE, US |

## Why this score
- Fast 145-day review: this device is a strong predicate for similar products.
- Abbreviated 510(k): a modification of an existing device.
- Posted 15 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261788). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.