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
6409–6432 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 16, 2010
SYNGO TRUED SOFTWARE
K101749 · LLZ
Siemens Medical Solutions
Radiology · 55d
Cleared Aug 16, 2010
21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112...
K090947 · LLZ
Totoku Electric Co., Ltd.
Radiology · 500d
Cleared Aug 12, 2010
GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND
K102113 · IYN
Ge Medical Systems China Co., Ltd.
Radiology · 15d
Cleared Aug 12, 2010
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND...
K101757 · ITX
Sonosite,Inc.
Radiology · 50d
Cleared Aug 10, 2010
SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
K101960 · HEP
Edan Instruments, Inc.
Radiology · 29d
Cleared Aug 10, 2010
VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR
K101751 · IYE
Varian Medical Systems, Oncology Systems
Radiology · 49d
Cleared Aug 10, 2010
SYNGO. PLAZA VA20A
K101666 · LLZ
Siemens AG Medical Solutions
Radiology · 57d
Cleared Aug 09, 2010
ALLURA XPER OR TABLE SERIES
K102005 · OWB
Philips Medical Systems North...
Radiology · 25d
Cleared Aug 09, 2010
CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC...
K101452 · KPT
Capintec, Inc.
Radiology · 76d
Cleared Aug 09, 2010
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717
K091090 · MQB
E-Woo Technology
Radiology · 480d
Cleared Aug 06, 2010
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
K102065 · IYN
Medison Co., Ltd.
Radiology · 14d
Cleared Aug 06, 2010
MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235
K101508 · LHN
Ion Beam Applications S.A.
Radiology · 66d
Cleared Aug 04, 2010
DUSIMETRY CHECK
K101503 · IYE
Math Resolutions, LLC
Radiology · 64d
Cleared Aug 04, 2010
SCANDIA-45 GAMMA CAMERA SYSTEM
K101391 · IYX
Scandia Corporation
Radiology · 78d
Cleared Aug 04, 2010
CORRIDOR4DM V2010 MODEL: V2010
K101279 · LLZ
Invia
Radiology · 90d
Cleared Aug 04, 2010
ICAD VERALOOK CTC CAD SOFTWARE
K091529 · JAK
Icad, Inc.
Radiology · 439d
Cleared Aug 03, 2010
SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q,...
K101289 · MQB
Air Techniques, Inc.
Radiology · 88d
Cleared Jul 28, 2010
PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601
K101949 · MOS
Shanghai Chenguang Medical...
Radiology · 16d
Cleared Jul 28, 2010
MROPEN
K101295 · LNH
Paramed S.R.L.
Radiology · 79d
Cleared Jul 27, 2010
PROWESS PANTHER PROARC, MODEL VERSION 5.0
K101076 · MUJ
Prowess, Inc.
Radiology · 99d
Cleared Jul 26, 2010
SYNAPSE 3D BASIC TOOLS
K101662 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 42d
Cleared Jul 26, 2010
MED-SEG, MODEL BTMS 1000
K092328 · LLZ
Bartron Medical Imaging, Inc.
Radiology · 356d
Cleared Jul 23, 2010
INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
K101833 · OWB
Infimed, Inc.
Radiology · 22d
Cleared Jul 21, 2010
IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235
K100766 · LHN
Ion Beam Applications S.A.
Radiology · 126d