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
8713–8736 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 21, 2003
TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3...
K032490 · LNH
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Aug 18, 2003
PEM 2400 PET SCANNER
K032063 · KPS
Pem Technologies
Radiology · 46d
Cleared Aug 15, 2003
NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007
K032372 · JAQ
Nucletron Corporation
Radiology · 14d
Cleared Aug 14, 2003
DVNET MDV-PACS
K031816 · LLZ
Dvnet International Technology Co., Ltd.
Radiology · 63d
Cleared Aug 14, 2003
PHILIPS FRESCO RELEASE 1
K031836 · LLZ
Philips Medical Systems North America...
Radiology · 62d
Cleared Aug 14, 2003
MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC
K031866 · JAI
Med-Tec,Inc.
Radiology · 59d
Cleared Aug 14, 2003
ORTHOVIEW
K032401 · LLZ
Omsbar, Ltd.
Radiology · 10d
Cleared Aug 13, 2003
MODIFICATION TO E-SCAN XQ
K032121 · LNH
Esaote, S.P.A.
Radiology · 35d
Cleared Aug 12, 2003
CRYOCARE CS SURGICAL SYSTEM
K032333 · GEH
Endocare, Inc.
Radiology · 14d
Cleared Aug 11, 2003
RAMSOFT PACS, MODEL 3.0
K031562 · LLZ
Ramsoft, Inc.
Radiology · 84d
Cleared Aug 08, 2003
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
K031789 · ODG
Pentax Precision Instrument Corp.
Radiology · 59d
Cleared Aug 08, 2003
EMBRYON ULTRASOUND NEEDLE GUIDE
K032015 · MQE
Rocket Medical Plc
Radiology · 39d
Cleared Aug 07, 2003
SWIFT 2.0, MODEL 132.001
K031158 · JAQ
Nucletron Corp.
Radiology · 118d
Cleared Aug 07, 2003
OTP 1.2
K031349 · MUJ
Nucletron Corp.
Radiology · 100d
Cleared Aug 07, 2003
PRACTICEBUILDER 1-2-3
K031778 · LLZ
Erad Imagemedical Corp.
Radiology · 58d
Cleared Aug 06, 2003
CADSTREAM
K031779 · LLZ
Confirma, Inc.
Radiology · 57d
Cleared Aug 06, 2003
SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K032281 · IYN
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Aug 06, 2003
SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM
K032329 · IYN
Medison America, Inc.
Radiology · 8d
Cleared Aug 04, 2003
SQUEEZE-EASE MAMMOGRAPHY CUSHION
K031574 · IZH
S & S X-Ray Products, Inc.
Radiology · 76d
Cleared Aug 01, 2003
R 72
K030487 · KPW
Ralco S.R.L.
Radiology · 168d
Cleared Aug 01, 2003
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I
K032202 · LLZ
Planar Systems, Inc.
Radiology · 14d
Cleared Jul 31, 2003
RSV (RADIOLOGY SYSTEM VISIODENT
K031448 · EHD
Visiodent SA
Radiology · 85d
Cleared Jul 31, 2003
FILMLESS CLINIC
K031704 · LLZ
Connect Imaging, Inc.
Radiology · 59d
Cleared Jul 30, 2003
MR FIBER OPTIC ECG GATING SYSTEM
K031731 · LNH
Sa Instruments, Inc.
Radiology · 56d