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
8737–8760 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 22, 2003
INNOVA 3100
K031637 · OWB
GE Medical Systems
Radiology · 87d
Cleared Aug 22, 2003
VIATRONIX V3D EXPLORER, REVISION 1.2
K032483 · LLZ
Viatronix, Inc.
Radiology · 10d
Cleared Aug 22, 2003
EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
K032503 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 9d
Cleared Aug 21, 2003
SHIMADZU COLLIMATOR R-30H
K031771 · IZX
Shimadzu Corp.
Radiology · 73d
Cleared Aug 21, 2003
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8
K032090 · MOS
Mri Devices Corp.
Radiology · 45d
Cleared Aug 21, 2003
NOMOS CORVUS 5.0M
K032209 · MUJ
Nomos Corp.
Radiology · 34d
Cleared Aug 21, 2003
QSC-127 SHOULDER ARRAY COIL SET
K032429 · MOS
Mri Devices Corp.
Radiology · 15d
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