Medical Device Clearances & Approvals
Authoritative tracking of FDA 510(k), PMA, De Novo decisions, and digital health technology.
Last Synced: 2026-11-14 19:22 UTC
Indexed Devices
297
✦ AI/ML Enabled
4
New Devices
162
Modifications
135
| Submission ID | Determination | Lifecycle | AI/ML | Device Name & Code | Applicant & Market Status | Decision Date | Review Speed | Action |
|---|---|---|---|---|---|---|---|---|
| K263109 | CLEARED | NEW | AI |
EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)
Code: QAS
• Radiology
|
Ever Fortune.Ai, Co., Ltd.
PRIV
|
2026-10-30 | 56d | |
| K261679 | CLEARED | NEW | AI |
BlineSlide
Code: POK
• Radiology
|
Deep Breathe, Inc.
PRIV
|
2026-10-23 | 155d | |
| K262062 | CLEARED | NEW | AI |
CINA-Aneurysm
Code: QBS
• Radiology
|
Avicenna.Ai
PRIV
|
2026-10-20 | 124d | |
| K262147 | CLEARED | NEW | AI |
CINA-Aneurysm+
Code: QIH
• Radiology
|
Avicenna.Ai
PRIV
|
2026-10-19 | 116d |
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