510(k) K261788
- Device
- Eden PACS
- Applicant
- Higia., Inc. d/b/a Eden
- 510(k) number
- K261788
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-10-21
- Date received
- 2026-05-29
- Regulation
- 892.2050
- Classification name
- System, Image Processing, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Daniel Medina
- Address
- 300 Delaware Ave. Suite 210 #215 Wilmington DE US 19801 19801
FDA Registration Numbers#
- 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
- 3008548323
- 2126677
- 3010684280
- 3036756245
- 3017004860
- 3008027912
- 3013844297
- 3027347389
- 3019674997
- 8020021
- 3007603826
- 3015509619
- 3044622018
- 3007350723
- 2134213
- 3005450718
- 3010822102
- 3004434200
- 3011189058
- 3005517190
- 3017233423
- 3003314115
- 3015895145
- 3003402534
- 3014809646
- 3009077524
- 3009134655
- 8030233
- 3027329005
- 3011545155
- 3008012314
- 3016075969
- 9615992
- 3005914761
- 3009543051
- 9613299
- 3008007310
- 3009149931
- 3018405359
Source Documents#
Other 510(k) Records For Product Code LLZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261531 | PV-iCurve Pro | Perception Vision Medical Technology Co., Ltd. | 2026-10-21 |
| K263048 | Syngo Carbon Space (VA4) | Siemens Healthineers AG | 2026-09-29 |
| K261874 | Syneris PACS v.1.0.1.0 | Syneris | 2026-09-23 |
| K262442 | HipStudio Analysis | Replasia BV | 2026-09-22 |
| K261855 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | 2026-09-18 |
| K254214 | OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2026-09-15 |
| K261861 | SPINEsim v1.0 | Mdsim S.A. | 2026-09-15 |
| K262060 | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | 2026-09-04 |
| K261500 | KBA3D (v2.4.0) | S.M.A.I.O | 2026-08-17 |
| K262449 | AdvaView | ADVAHEALTH SOLUTIONS, LLC | 2026-08-14 |
| K261916 | NeuroQuant PET | Cortechs Labs, Inc. | 2026-08-12 |
| K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-31 |
| K260588 | Cleerly LABS | Cleerly, Inc. | 2026-07-29 |
| K262462 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026-07-24 |
| K262143 | ImageGrid StreamVue | Candelis, Inc. | 2026-07-23 |