510(k) K211431
- Device
- Breastscape V1.0
- Applicant
- Olea Medical
- 510(k) number
- K211431
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-08-02
- Date received
- 2021-05-07
- 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
Applicant Contact#
- Contact
- Nathalie Palumbo
- Address
- 93 Ave. Des Sorbiers Zi Athelia Iv La Ciotat FR 13600 13600
FDA Registration Numbers#
- 3016819165
- 3024812789
- 3004141078
- 3001722928
- 3017426576
- 3044776706
- 3019216
- 3013868968
- 3042940623
- 3016965352
- 3018094310
- 3002183074
- 3020928588
- 3015425142
- 3010952312
- 3032008018
- 3005739655
- 3015509619
- 3015218501
- 3027160711
- 3027977501
- 3017936978
- 3013306229
- 3004977335
- 9616251
- 3045521711
- 3011063460
- 3016579137
- 3024820186
- 3004972322
- 3032109181
- 3008496839
- 3044737887
- 3011950073
- 3014678441
- 3017840913
- 9616047
- 3011015597
- 3014132130
- 3015516266
- 3012761544
- 8022257
- 3035950510
- 3008007310
- 3015169361
- 9612283
- 9710602
- 3036725840
- 3010398867
- 9611992
- 3021027284
- 3035455070
- 3008693672
- 3000976525
- 3005383085
- 3042175844
- 3016461002
- 3025430791
- 3028006458
- 3023245
- 3012747207
- 3024972425
- 3029900829
- 3018733944
- 9710645
- 3033508292
- 8043933
- 3016759115
- 3035386366
- 3025343020
- 3014491269
- 3013757696
- 3007734888
- 2134213
- 3029937167
- 9617277
- 1818910
- 3026970882
- 3014938447
Source Documents#
Other 510(k) Records For Product Code QIH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252571 | mdprostate | Mediaire GmbH | 2026-08-07 |
| K253902 | RealGUIDE | 3DIEMME SRL | 2026-08-04 |
| K253835 | Affinity | Hermes Medical Solutions AB | 2026-07-31 |
| K260980 | cmAngio® V2.0 | Curemetrix, Inc. | 2026-07-30 |
| K261210 | Cleerly Plaque | Cleerly, Inc. | 2026-07-29 |
| K260192 | DIANA | ROPCA ApS | 2026-07-24 |
| K261349 | SwiftMR | Airs Medical, Inc. | 2026-07-24 |
| K254096 | VELMENI for DENTISTS (V4D) 3D | Velmeni, Inc. | 2026-07-23 |
| K261535 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | 2026-07-20 |
| K260206 | SkeletonPlanner | UPlanner B.V. - Presurgeo | 2026-07-15 |
| K260973 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026-07-07 |
| K253628 | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. | 2026-06-29 |
| K253969 | ADAS 3D | Adas3D Medical S.L. | 2026-06-29 |
| K253786 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | 2026-06-25 |
| K260316 | CMN Capillary Function with Oncology Virtual Expert | Cercare Medical A/S | 2026-06-22 |
Legacy Summary#
summary
FDA Review#
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