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
6745–6768 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 27, 2009
RADCALC SOFTWARE, VERSION 6.0
K090531 · MUJ
Lifeline Software, Inc.
Radiology · 89d
Cleared May 27, 2009
FLEXIPLAN 3D AND 3D+
K091145 · MUJ
Isodose Control B.V.
Radiology · 37d
Cleared May 27, 2009
PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
K091195 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 34d
Cleared May 26, 2009
GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND
K091374 · IYO
Ge Medical Systems China Co., Ltd.
Radiology · 15d
Cleared May 22, 2009
CAAS MR FLOW 1.0
K090155 · LLZ
Pie Medical Imaging BV
Radiology · 120d
Cleared May 22, 2009
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
K090461 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 88d
Cleared May 22, 2009
CARESTREAM DRYVIEW 5850 LASER IMAGER
K090469 · LMC
Carestream Health, Inc.
Radiology · 88d
Cleared May 20, 2009
SYNGO TRUED
K091373 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 9d
Cleared May 19, 2009
EG-3670URK
K090196 · ODG
Pentax Medical Company
Radiology · 112d
Cleared May 19, 2009
EG-3870UTK
K090197 · ODG
Pentax Medical Company
Radiology · 112d
Cleared May 18, 2009
SYNGOCIRCULATION DYNAMICPET, VERSION 1.0
K083327 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 187d
Cleared May 18, 2009
WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
K090062 · MQB
Direct Digital Imaging Technology...
Radiology · 129d
Cleared May 18, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
K090672 · MQB
Agfa Healthcare N.V.
Radiology · 66d
Cleared May 18, 2009
ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
K090749 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 59d
Cleared May 18, 2009
MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY...
K091009 · IYN
Esaote, S.P.A.
Radiology · 39d
Cleared May 18, 2009
UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270,...
K091154 · JAQ
Nucletron Corporation
Radiology · 27d
Cleared May 15, 2009
ZIEHM VISION RFD
K083545 · OWB
Ziehm Imaging, Inc.
Radiology · 168d
Cleared May 15, 2009
SYNGO US WORKPLACE
K091286 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared May 15, 2009
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0
K091295 · ITX
Toshiba America Medical Systems, In.C
Radiology · 11d
Cleared May 14, 2009
WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING...
K091073 · KPS
Ultraspect , Ltd.
Radiology · 30d
Cleared May 12, 2009
SEGMENT
K090833 · LLZ
Medviso
Radiology · 47d
Cleared May 08, 2009
SYNGO RT THERAPIST CONNECT
K090683 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared May 08, 2009
NEUROPET
K091269 · KPS
Photodetection Systems, Inc.
Radiology · 8d
Cleared May 07, 2009
SPEQ ULTRASOUND SYSTEM
K090505 · IYO
Signostics Pty, Ltd.
Radiology · 70d