FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
6817–6840 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 16, 2009
VERADIUS, MODEL 718-130
K090590 · OWB
Philips Medical Systems North America...
Radiology · 12d
Cleared Mar 13, 2009
BEL-CYPHER, MODEL Y977
K090020 · MUH
Takara-Belmont Co., Ltd.
Radiology · 67d
Cleared Mar 13, 2009
LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
K090095 · LLZ
Broncus Technologies, Inc.
Radiology · 57d
Cleared Mar 13, 2009
VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND
K090214 · IYO
Verathon Incorporated
Radiology · 43d
Cleared Mar 13, 2009
DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ...
K090229 · IYN
Chang Gung Medical Supplies &...
Radiology · 42d
Cleared Mar 11, 2009
SEDECAL, MILLENNIUM PLUS
K090279 · KPR
Sedecal., Sa.
Radiology · 35d
Cleared Mar 10, 2009
ADX4000-L, DX3000-L
K083532 · MUH
Dexcowin Co., Ltd.
Radiology · 102d
Cleared Mar 09, 2009
PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION...
K082964 · LNH
Prism Clinical Imaging, Inc.
Radiology · 157d
Cleared Mar 09, 2009
CARDIUS 3 X-ACT
K083649 · KPS
Digirad Corp.
Radiology · 90d
Cleared Mar 09, 2009
CLEARVUE PRONE BREAST TREATMENT TABLE
K090349 · IYE
Orbital Therapy, LLC
Radiology · 26d
Cleared Mar 05, 2009
CSBP-001A BODY PERFUSION SYSTEM
K090504 · JAK
Toshibamedical Systems Corporation
Radiology · 7d
Cleared Mar 04, 2009
DATACOM DC PACS
K083182 · LLZ
Datacom Technology Corp.
Radiology · 127d
Cleared Mar 04, 2009
BODYVIZ, MODEL 100
K090295 · LLZ
Visual Medical Solutions, LLC
Radiology · 27d
Cleared Mar 02, 2009
RADIONICS XKNIFE HDRT SYSTEM
K083414 · MUJ
Integra Radionics, Inc.
Radiology · 104d
Cleared Feb 27, 2009
SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS
K090238 · KPR
Sedecal., Sa.
Radiology · 25d
Cleared Feb 25, 2009
CONTEC POCKET FETAL DOPPLER
K082480 · KNG
Contec Medical System Co., Ltd.
Radiology · 181d
Cleared Feb 25, 2009
VISIX IMAGING
K082623 · LLZ
Televere Systems
Radiology · 169d
Cleared Feb 25, 2009
BONEVUE
K083691 · LLZ
Micromri, Inc.
Radiology · 75d
Cleared Feb 24, 2009
NEONATE HEAD AND BODY COILS
K083541 · MOS
Advanced Imaging Research, Inc.
Radiology · 88d
Cleared Feb 24, 2009
RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS
K083645 · MQB
5 Star Medical, Inc.
Radiology · 77d
Cleared Feb 23, 2009
RESOLUTIONMD, RELEASE 2.1
K082693 · LLZ
Calgary Scientific, Inc.
Radiology · 161d
Cleared Feb 20, 2009
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K090334 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 10d
Cleared Feb 19, 2009
PRESCISION OPTION
K082775 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 150d
Cleared Feb 19, 2009
NEUROSCAPE
K083491 · LLZ
Olea Medical
Radiology · 86d