510(k) K241561
- Device
- MammoScreen BD
- Applicant
- Therapixel
- 510(k) number
- K241561
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-02
- Date received
- 2024-05-31
- 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
- Quentin De Snoeck
- Address
- 455 Promenade Des Anglais Nice FR 06200 06200
FDA Registration Numbers#
- 3003594449
- 3019544554
- 8022257
- 3016819165
- 3016461002
- 3004141078
- 3027160711
- 3016965352
- 3042902406
- 3044776706
- 3013757696
- 3019878658
- 3009758186
- 3008284470
- 3035373446
- 3030598283
- 2518586
- 3025602618
- 3014491269
- 1836549
- 9611343
- 3032109181
- 9710602
- 3015537315
- 9710645
- 3014938447
- 3015516266
- 3032008018
- 3042852277
- 3008007310
- 3009196578
- 3010703925
- 3002619337
- 3010656400
- 3006209933
- 3043494619
- 3014809646
- 3024812789
- 3019541896
- 3015173173
- 3018064242
- 9616047
- 3045521711
- 1818910
- 3029900829
- 3011015597
- 3020928588
- 3014146081
- 3036725840
- 3000976525
- 3022719380
- 2126677
- 3017102960
- 3028006458
- 3013306229
- 3043625056
- 3021027284
- 3015612252
- 3030089065
- 3047514296
- 3014132130
- 3042470731
- 8020021
- 3042175844
- 3017210169
- 3029904428
- 3010398867
- 3012747207
- 8043836
- 1000432246
- 3047889344
- 3005383085
- 3019216
- 3015763655
- 3017167291
- 3009731198
- 3017840913
- 3011063460
- 3002183074
Source Documents#
Other 510(k) Records For Product Code QIH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261733 | Ligence Heart | UAB Ligence | 2026-10-07 |
| K262134 | NeuroDR | Deep Reasoning Ai, Inc. | 2026-10-07 |
| K260523 | QGuideCT (1.0) | Medis Medical Imaging Systems BV | 2026-10-05 |
| K260055 | syngo.CT Brain Quantification | Siemens Medical Solutions USA, Inc. | 2026-09-25 |
| K262390 | BoneXpert | Visiana | 2026-09-22 |
| K261368 | Rapid Platform (R6.7) | Ischemaview, Inc. | 2026-09-21 |
| K261623 | EchoPAC Software Only / EchoPAC Plug-in (v211) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-09-16 |
| K261677 | Artificial Intelligence Renal Assessment (AIRA) Version 1 | Aramis Global AI Consultancies, LLC | 2026-09-15 |
| K260879 | 4DM | INVIA, LLC | 2026-09-10 |
| K261795 | Quicktome Software Suite | Omniscient Neurotechnology Pty, Ltd. | 2026-09-10 |
| K251417 | ReVISION 2 | Argus Cognitive, Inc. | 2026-09-09 |
| K260525 | NextMR Spine | MRI2CT, Inc. | 2026-09-04 |
| K260811 | Heartvue.Proton | Heartvue.ai, Inc. | 2026-08-26 |
| K261595 | Ceevra Reveal 4 | Ceevra, Inc. | 2026-08-25 |
| K260584 | BoneMRI | Mriguidance B.V. | 2026-08-21 |