510(k) K223268
- Device
- BrainInsight
- Applicant
- Hyperfine, Inc.
- 510(k) number
- K223268
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-16
- Date received
- 2022-10-24
- 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
- Christine Kupchick
- Address
- 351 New Whitfield St. Guilforf CT US 06437 06437
FDA Registration Numbers#
- 3001675293
- 3015169361
- 3001722928
- 1836549
- 3008284470
- 3009196578
- 3025430791
- 3025343020
- 3008496839
- 3014310698
- 3029915548
- 8030233
- 3042248552
- 3015218501
- 2134213
- 3019216
- 3038177848
- 3034527804
- 3030412475
- 3004141078
- 3015173173
- 3013757696
- 3016461002
- 3020928588
- 3032008018
- 3014678441
- 3017840913
- 3016585383
- 1826555
- 3024972425
- 3045521711
- 3006985147
- 3045817397
- 3017058304
- 3007675959
- 3033527241
- 3017297314
- 3018733944
- 3011015597
- 9611343
- 3033508292
- 3017936680
- 3019541896
- 3012987001
- 3021032044
- 2126677
- 3029923647
- 3023245
- 3030598283
- 3008693672
- 3005403518
- 9617277
- 9680269
- 3003775006
- 3011763071
- 3015763655
- 3014665798
- 3024812789
- 3024820186
- 3006165260
- 3004977335
- 3042928350
- 3035950510
- 3029900829
- 3005739655
- 9614698
- 3017894900
- 3011189058
- 3009758186
- 3018064242
- 3027986210
- 3014938447
- 3012981490
- 3000126629
- 3025603301
- 8022257
- 3042243683
- 3007734888
- 3039211310
Source Documents#
Other 510(k) Records For Product Code QIH#
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|---|---|---|---|
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| K253172 | MediAI-OA | Crescom Co., Ltd. | 2026-06-15 |
| K253690 | LungMaps | Siemens Healthineers AG | 2026-06-15 |
| K260406 | Brainomix 360 Hyperdensity | Brainomix Limited | 2026-06-12 |
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| K260497 | DEEPVESSEL Plaque | Keya Medical Technology Co., Ltd. | 2026-06-04 |
| 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 |