Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden
Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden (Delaware): 510(k) cleared for Higia., Inc. d/b/a Eden. Its amount of 145 is above the median of 138 (54th percentile). Dated 15 days ago, it is in the active follow-up window. Score 41/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 145 · 54th percentile of 414 FDAPulse records · 1.1x the median
Free preview: all 14 published fields of this record are shown below. Locked: 24 related DE FDAPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 54th of 414 (median 138, 1.1x median) |
| Peer records CSV (25 DE records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Free first: a 10-record sample of DE records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden + all 25 DE records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-21
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (DE first): colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gas · Endox High Level Disinfectant (K254094) · Actolind® (06.3637. Actolind® Gel Plus) (K254168) · UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operat · KARL STORZ SUPRALOOP (K254303) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 21:30:53 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden's amount: 54th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Delaware peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
41 / 100 Predicate Speed & CAPA Advisory Opportunity 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.
What is the FDAPulse record for Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden in Delaware?
Eden PACS (K261788) by Higia., Inc. d/b/a Eden was cleared on 2026-10-21 after 145 days of review.
How does Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden compare to other Delaware FDAPulse records?
Its amount of 145 sits in the upper half (54th percentile) of 414 records; the median is 138. It is 15 days old, still within a typical 45-day follow-up window.
Eden PACS (K261788) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Eden PACS (K261788) | DE | 2026-10-21 |
| VenusCT (K260510) | CA | 2026-10-19 |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
Related records
- VenusCT (K260510): 510(k) cleared for Linatech, LLC
- AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd.
- Vista AI Scan (K260092): 510(k) cleared for Vista AI, Inc.
- syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc.
- Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc.
- OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd.
- BoneVue (K254072): 510(k) cleared for Curvebeam AI / Curvebeam, LLC
- BlineSlide (K261679): 510(k) cleared for Deep Breathe, Inc.
- Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd.
- PV-iCurve Pro (K261531): 510(k) cleared for Perception Vision Medical Technology Co., Ltd.
- Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa
- Single-Use EBUS Balloon (K261616): 510(k) cleared for Micro-Tech (Nanjing) Co., Ltd.
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Radiology devices
More Delaware public-record feeds
Delaware Public Education Organization Directory Pulse in Delaware Largest U.S. Greenhouse Gas Emitters by Company, Sector & State (EPA GHGRP) in Delaware FEMA Hazard Mitigation Project Tracker in Delaware Federal Alcohol Permit Holder Directory in Delaware New NSF Research Awards by Institution in Delaware School & Library E-Rate Contracts Up for Rebid in Delaware New Grants by Vendor Procurement Need in Delaware Carrier Out-of-Service Alerts in Delaware
How to monitor Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden and peer radiology records
Get new FDAPulse records like Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get clearances and recalls like this every day
FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
Often used together
- NPIPulse
- EPAPulse
- Municipal Public Works Prime Contract Operating Permit Renewal Pulse
- TrialRecruitmentPageAudit
- SubdomainShadowPulse
- MigrationSignalRadar
Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.