510(k) K240094
- Device
- LumiNE US; Lumi
- Applicant
- Augmedit B.V.
- 510(k) number
- K240094
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-10
- Date received
- 2024-01-12
- Regulation
- 892.2050
- Classification name
- Automated Radiological Image Processing Software
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Claartje Ypma
- Address
- Galerij 15 Naarden NL 1411 LH 1411 LH
FDA Registration Numbers
- 3033527241
- 9710602
- 3013497030
- 3007734888
- 3019544554
- 3016819165
- 3013561205
- 3005225421
- 3016446349
- 3030655434
- 3024972425
- 3028006458
- 3007194257
- 3002183074
- 3013844297
- 8041160
- 3015173173
- 8022257
- 8030233
- 1423253
- 3015169361
- 3026970882
- 3004977335
- 3017487805
- 3016965352
- 8043933
- 3007545404
- 3021637148
- 3033509898
- 3042955884
- 3030446846
- 3025343020
- 3032008018
- 2936485
- 3018094310
- 3024820186
- 3009758186
- 3010102386
- 3009196578
- 3006985147
- 3008693672
- 3002808157
- 3015537315
- 3035386366
- 1644408
- 3001675293
- 9611343
- 1651903
- 2532090
- 3042175844
- 3008007310
- 3010398867
- 3015509619
- 1000432246
- 9680269
- 3013552417
- 3021907554
- 3005403518
- 3014146081
- 3016579137
- 3042243683
- 3000976525
- 1836549
- 1818910
- 3014132130
- 9610482
- 3010703925
- 3014745562
- 3030088963
- 9616251
- 3015276088
- 3029937167
- 3035373446
- 3035950510
- 3029915548
- 3017173128
- 3005930550
- 3014809646
- 3039211310
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08720892617637 | LumiNE US | AugmedIT B.V. | 2026-02-13 |
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