Eden PACS
Higia., Inc. d/b/a Eden · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Wilmington
- Advisory committee description
- Radiology
- Address 1
- 300 Delaware Ave.
- Address 2
- Suite 210 #215
- Statement or summary
- Summary
- Product code
- LLZ
- Zip code
- 19801
- Applicant
- Higia., Inc. d/b/a Eden
- Decision date
- 2026-10-21
- Decision code
- SESE
- Country code
- US
- Device name
- Eden PACS
- Advisory committee
- RA
- Contact
- Daniel Medina
- K number
- K261788
- State
- DE
- Date received
- 2026-05-29
- Review advisory committee
- RA
- Postal code
- 19801
- Decision description
- Substantially Equivalent
- Clearance type
- Abbreviated
- Harmonized identifiers (openFDA)
- Device name
- System, Image Processing, Radiological
- Medical specialty description
- Radiology
- Regulation number
- 892.2050
- Device class
- 2
- Registration number
- 3001052305, 3005406110, 3017545364, 3005172103, 9617978, 3004706313, 3008487708, 1226544, 3009341091, 3044776706, 3010656400, 3038189169, 3007362683, 3007993775, 1061158, 3014232555, 3003757027, 3014991167, 9617592, 3013634985, 3023217364, 1054415, 3013535906, 3026047529, 3019878658, 3005225421, 3030655434, 3009156722, 3010445368, 8020825, 3011676026, 3008364043, 3045521711, 3014635169, 2954921, 9615439, 3011015597, 3003989064, 3035371452, 3019544554 +603 more
- FEI number
- 3001052305, 3005406110, 3017545364, 3005172103, 3004706313, 3008487708, 3009341091, 3044776706, 3002808188, 3010656400, 3038189169, 3007362683, 3007993775, 3014232555, 3003757027, 3014991167, 3013634985, 3023217364, 3013535906, 3026047529, 3019878658, 3005225421, 3030655434, 3009156722, 3010445368, 3011676026, 3008364043, 3045521711, 3014635169, 3011015597, 3003989064, 3035371452, 3019544554, 3008548323, 3014269683, 3002821504, 2126677, 3002619595, 3010684280, 3003861317 +603 more