FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: QIH ×
313 results
241–264 of 313
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 22, 2023
Bladder AI (AIBV01)
K230497 · QIH
Exo, Inc.
Radiology · 118d
Cleared Jun 16, 2023
DeepCatch
K223556 · QIH
Medical IP Co., Ltd.
Radiology · 200d
Cleared Jun 16, 2023
IB Lab LAMA
K223646 · QIH
Ib Lab GmbH
Radiology · 192d
Cleared Jun 06, 2023
FEops HEARTguideTM, FEops HEARTguideTM ALPACA
K223855 · QIH
Feops NV
Radiology · 165d
Cleared May 02, 2023
SIS System
K230977 · QIH
Surgical Information Sciences, Inc.
Radiology · 27d
Cleared Apr 25, 2023
Ceevra Reveal 3
K222676 · QIH
Ceevra, Inc.
Radiology · 231d
Cleared Apr 21, 2023
ViewFinder Software Version 1.1
K223501 · QIH
Elaitra, Ltd.
Radiology · 151d
Cleared Apr 13, 2023
CerebralGo Plus
K213986 · QIH
Yukun (Beijing) Technology Co., Ltd.
Radiology · 479d
Cleared Mar 31, 2023
Formus Hip
K213272 · QIH
Formus Labs, Ltd.
Radiology · 547d
Cleared Mar 28, 2023
RadioLens v1.0
K222174 · QIH
Synapsica
Radiology · 250d
Cleared Mar 22, 2023
MPXA-2000
K222036 · QIH
Medipixel, Inc.
Radiology · 254d
Cleared Feb 22, 2023
BoneMRI v1.6
K230197 · QIH
Mriguidance B.V.
Radiology · 28d
Cleared Feb 06, 2023
Videa Perio Assist
K223296 · QIH
Videahealth, Inc.
Radiology · 103d
Cleared Feb 01, 2023
LVivo IQS
K222970 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 127d
Cleared Feb 01, 2023
Rapid RV/LV
K223396 · QIH
Ischemaview, Inc.
Radiology · 85d
Cleared Jan 23, 2023
Clarius AI
K222406 · QIH
Clarius Mobile Health Corp.
Radiology · 167d
Cleared Dec 23, 2022
AVIEW
K214036 · QIH
Coreline Soft Co., Ltd.
Radiology · 365d
Cleared Dec 16, 2022
Saige-Density
K222275 · QIH
DeepHealth, Inc.
Radiology · 140d
Cleared Dec 16, 2022
BrainInsight
K223268 · QIH
Hyperfine, Inc.
Radiology · 53d
Cleared Nov 21, 2022
SIS System (Version 5.6.0)
K223032 · QIH
Surgical Information Sciences, Inc.
Radiology · 53d
Cleared Nov 16, 2022
BoneMRI v1.4
K221762 · QIH
Mrlguidance B.V.
Radiology · 152d
Cleared Nov 14, 2022
Syngo Dynamics (Version VA40F)
K222428 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 95d
Cleared Oct 18, 2022
Spine CAMP™
K221632 · QIH
Medical Metrics, Inc.
Radiology · 134d
Cleared Sep 30, 2022
QIR Suite
K211611 · QIH
Casis Cardiac Simulation & Imaging...
Radiology · 493d