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
6433–6456 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 07, 2010
FETAL MONITOR MODEL: BT-200T
K100885 · HGM
Bistos Co., Ltd.
Radiology · 69d
Cleared Jun 07, 2010
MODIFICATION TO SCINTRON IV
K101013 · KPS
Miegmbh
Radiology · 56d
Cleared May 26, 2010
SYNGO.CT CORONARY ANALYSIS
K100637 · JAK
Siemens AG Medical Solutions
Radiology · 82d
Cleared May 21, 2010
SONIC SHOT GX
K091734 · IZQ
Nemoto Kyorindo Co., Ltd.
Radiology · 344d
Cleared May 21, 2010
ULTRA DCI MODEL 5000
K100363 · IYO
Ultrasound Medical Devices, Inc.
Radiology · 98d
Cleared May 21, 2010
DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200
K100626 · KNG
Shenzhen Biocare Electronics Co., Ltd.
Radiology · 77d
Cleared May 21, 2010
SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X...
K100847 · KXK
Biocompatibles, Inc.
Radiology · 57d
Cleared May 21, 2010
SYNC-RX SYSTEM, MODEL AS00010
K100849 · IZI
Sync-Rx, Ltd.
Radiology · 56d
Cleared May 14, 2010
MRI PATIENT POSITIONING DEVICES
K093738 · LNH
Medtec, Inc.
Radiology · 161d
Cleared May 13, 2010
TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL...
K092164 · OQQ
Shenzhen Delicate Electronics Co., Ltd.
Radiology · 301d
Cleared May 12, 2010
MINXRAY, MODEL: BPD60
K091255 · EHD
Minxray, Inc.
Radiology · 378d
Cleared May 12, 2010
PLANMECA PROMAX 3D MAX
K093590 · MUH
Planmeca Oy
Radiology · 174d
Cleared May 11, 2010
OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500
K100691 · IYE
Bionix Development Corp.
Radiology · 62d
Cleared May 07, 2010
MEDCOM RT-VIEWER SYSTEM
K100056 · MUJ
Medcom GmbH
Radiology · 119d
Cleared May 07, 2010
SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827
K100619 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 64d
Cleared May 05, 2010
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K100830 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 42d
Cleared Apr 30, 2010
ILUMA VISION MODEL VERSION 2.2
K094064 · LLZ
3M Imtec
Radiology · 120d
Cleared Apr 30, 2010
CAAS QVA 3D, CAAS QCA 3D
K100292 · LLZ
Pie Medical Imaging BV
Radiology · 87d
Cleared Apr 30, 2010
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
K101041 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 16d
Cleared Apr 29, 2010
DOPPLER FETAL HEARTBEAT RATE DETECTOR
K090510 · KNG
Shenzhen Bestman Instrument Co., Ltd.
Radiology · 427d
Cleared Apr 26, 2010
VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K092171 · MUH
Genoray Co., Ltd.
Radiology · 279d
Cleared Apr 26, 2010
KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM
K093478 · MUH
Trophy
Radiology · 168d
Cleared Apr 23, 2010
MINXRAY MODEL CMDR-2S
K100449 · IZL
Minxray, Inc.
Radiology · 65d
Cleared Apr 23, 2010
ERGO IMAGING SYSTEM
K100838 · IYX
Digirad Corp.
Radiology · 30d