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: Radiology ×
15,589 results
8233–8256 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 19, 2004
SECOND LOOK VIEWER
K042697 · LLZ
Icad, Inc.
Radiology · 50d
Cleared Nov 19, 2004
SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250
K043025 · KPR
Analogic Corp.
Radiology · 16d
Cleared Nov 19, 2004
3VISEON
K043097 · LLZ
3Mensio Medical Imaging BV
Radiology · 10d
Cleared Nov 18, 2004
IOP8 INTRA OPERATIVE PROBE
K032315 · ITX
Huntleigh Healthcare, Inc.
Radiology · 479d
Cleared Nov 18, 2004
ADVANCED LUNG ANALYSIS II
K042694 · OEB
GE Medical Systems
Radiology · 49d
Cleared Nov 18, 2004
BEST MODEL # 81-01 SERIES IR-192 SOURCES
K042786 · KXK
Best Medical International, Inc.
Radiology · 43d
Cleared Nov 18, 2004
URS LP DIGITAL, MILLENNIUM, RADPRO
K042876 · KPR
Sedecal., Sa.
Radiology · 31d
Cleared Nov 18, 2004
SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR
K043002 · IZL
Sedecal., Sa.
Radiology · 17d
Cleared Nov 18, 2004
PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A
K043111 · JAK
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Nov 17, 2004
NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A
K043078 · IYO
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Nov 16, 2004
RESTITU
K041937 · IYE
Resonant Medical, Inc.
Radiology · 120d
Cleared Nov 16, 2004
SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM
K043016 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Nov 15, 2004
STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
K042733 · LHO
Standard Imaging, Inc.
Radiology · 45d
Cleared Nov 12, 2004
SENSATOUCH
K042250 · IYO
Aluna Management Co., Ltd.
Radiology · 84d
Cleared Nov 12, 2004
13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA
K042718 · MOS
Siemens Medi Cal Solutions, Inc.
Radiology · 43d
Cleared Nov 10, 2004
SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020
K041818 · ITX
Boston Scientific Corp
Radiology · 127d
Cleared Nov 10, 2004
VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM
K042188 · IYO
Volcano Therapeutics, Inc.
Radiology · 90d
Cleared Nov 10, 2004
ACCUPACH V
K042752 · IYO
Accutome Ultrasound, Inc.
Radiology · 37d
Cleared Nov 10, 2004
TRAUMACAD 1.2
K042816 · LLZ
Orthocrat, Ltd.
Radiology · 29d
Cleared Nov 09, 2004
GEMINI GXL
K042935 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 15d
Cleared Nov 08, 2004
SUPERDIMENSION/BRONCHUS
K042438 · JAK
Superdimension, Ltd.
Radiology · 61d
Cleared Nov 08, 2004
IMAGE MEDICAL ACQUISITION STATION (IMAS)
K042700 · LLZ
Erad Imagemedical Corp.
Radiology · 39d
Cleared Nov 05, 2004
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
K042617 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 42d
Cleared Nov 05, 2004
ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING...
K042619 · MUI
Sonotech, Inc.
Radiology · 42d