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#
- 3013410552
- 3011763071
- 3003768277
- 3005930550
- 3015169361
- 9612283
- 3028006458
- 3005225421
- 3013497030
- 3010656400
- 9616251
- 9613445
- 3003775006
- 3018064242
- 9611343
- 3021027284
- 3000126629
- 3013844297
- 3036495186
- 3030089065
- 3003594449
- 3011189058
- 3007734888
- 9611992
- 3005739655
- 3016759115
- 3015425142
- 3013757696
- 3026970882
- 3017426576
- 2032350
- 9710090
- 3020703662
- 3011205675
- 3017167291
- 3036725840
- 9611125
- 3013552417
- 3029900829
- 3023245
- 3015173173
- 2126677
- 9610482
- 3003899230
- 3017297314
- 3014809646
- 3034527804
- 9614698
- 3042248552
- 1836549
- 3001722928
- 3021032044
- 1226773
- 3017233423
- 3016824824
- 3017936978
- 3015537315
- 3042852277
- 3033557977
- 3029937167
- 3006209933
- 3017058304
- 3010102386
- 3038177848
- 3040335643
- 3025110425
- 3029904428
- 3017936680
- 3019216
- 3021887566
- 2532090
- 9680269
- 3031915908
- 3032109181
- 3042470731
- 9617277
- 3039211310
- 3030446846
- 3007545404
Source Documents#
Other 510(k) Records For Product Code QIH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260077 | OrthoGrid Hip AI® 4.0 | OrthoGrid Systems, Inc. | 2026-05-29 |
| K261405 | ANDI 2.2 | Imeka Solutions, Inc. | 2026-05-28 |
| K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | Canon Medical Informatics, Inc. | 2026-05-22 |
| K260234 | MSK Go | Smart Alfa Teknoloji San. Ve Tic. A.S. | 2026-05-21 |
| K254131 | BAC | DeepHealth, Inc. | 2026-05-21 |
| K261289 | UNiD™ Spine Analyzer (SW3002) | Medicrea International S.A.S. (Medtronic) | 2026-05-15 |
| K261273 | Neurophet AQUA | Neurophet., Inc. | 2026-05-15 |
| K252563 | Neurophet SCALE PET | Neurophet., Inc. | 2026-05-15 |
| K254120 | SubtleHD-CT (1.x) | Subtle Medical, Inc. | 2026-05-15 |
| K260032 | Morph | BeauBrain Healthcare, Inc. | 2026-05-13 |
| K254189 | Synapse 3D Base Tools (V7.2) | Fujifilm Corporation | 2026-04-30 |
| K254184 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2026-04-29 |
| K260785 | DS Core CBCT Anatomy | Dentsply Sirona | 2026-04-23 |
| K253077 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-22 |
| K252332 | Folliscan | Mim Fertility | 2026-04-20 |
Legacy Summary#
summary
FDA Review#
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