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
8809–8832 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 20, 2003
CONSULTIVA REPORT STATION, MODEL RS-1
K031248 · LLZ
Miramedica, Inc.
Radiology · 63d
Cleared Jun 20, 2003
INTEGRADWEB BY DYNAMIC IMAGING, INC.
K031311 · LLZ
Dynamic Imaging, Inc.
Radiology · 57d
Cleared Jun 20, 2003
HF MODULE WITH TRANSDUCERS
K031391 · IYO
Ophthalmic Technologies, Inc.
Radiology · 49d
Cleared Jun 20, 2003
C.CAM
K031825 · KPS
Danish Diagnostic Development A/S
Radiology · 7d
Cleared Jun 20, 2003
AUTOBONE
K031871 · JAK
Ge Medical Systems Europe
Radiology · 3d
Cleared Jun 20, 2003
ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING]
K031872 · KPS
Adac Laboratories
Radiology · 3d
Cleared Jun 19, 2003
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
K031571 · IZQ
E-Z-Em, Inc.
Radiology · 30d
Cleared Jun 17, 2003
PHILIPS EASYDIAGNOST ELEVA
K031535 · KPR
Philips Medical Systems North America...
Radiology · 32d
Cleared Jun 17, 2003
SKYLIGHT IMAGING SYSTEM
K031705 · KPS
Adac Laboratories
Radiology · 15d
Cleared Jun 11, 2003
CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
K031633 · MQB
Canon USA, Inc.
Radiology · 15d
Cleared Jun 10, 2003
SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000
K021360 · KXK
Med-Tec,Inc.
Radiology · 406d
Cleared Jun 09, 2003
READI-STRAND, MODEL PSSTRAND
K022705 · KXK
Worldwide Medical Technologies, LLC
Radiology · 299d
Cleared Jun 09, 2003
GE VIVID 7, MODEL FC0003XX
K031663 · IYN
General Electric Co.
Radiology · 11d
Cleared May 30, 2003
MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
K031552 · IYN
Medison America, Inc.
Radiology · 11d
Cleared May 29, 2003
VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC
K030699 · EAG
J. Morita Mfg. Corp.
Radiology · 84d
Cleared May 29, 2003
IPACS PRISM
K030751 · LLZ
Realtimeimage, Inc.
Radiology · 80d
Cleared May 29, 2003
KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW...
K030781 · LLZ
Eastman Kodak Company
Radiology · 79d
Cleared May 29, 2003
PREMIER III PHASED ARRAY CTL SPINE COIL
K031139 · MOS
Usa Instruments, Inc.
Radiology · 49d
Cleared May 29, 2003
ALPHA 5000 WRIST COIL
K031143 · MOS
Usa Instruments, Inc.
Radiology · 49d
Cleared May 29, 2003
SPIRIT III TOTALSENSE CARDIAC COIL
K031172 · MOS
Usa Instruments, Inc.
Radiology · 45d
Cleared May 23, 2003
FYRELINK VL
K030728 · LLZ
Mpacs, LLC
Radiology · 77d
Cleared May 23, 2003
ULTRAEKOGEL MODELS EK 2000 & EK 2001
K030889 · MUI
Inmed Ltda.
Radiology · 63d
Cleared May 23, 2003
GE 1.5T 8 CHANNEL TORSO COIL
K031209 · MOS
Ge Medical Systems, Inc.
Radiology · 36d
Cleared May 22, 2003
AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7
K031469 · JAK
Toshiba America Medical Systems, In.C
Radiology · 13d