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
8209–8232 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 13, 2005
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING
K042602 · MQB
Ge Medical Systems, LLC
Radiology · 111d
Cleared Jan 13, 2005
MIRAGE, RELEASE 5.5
K043441 · KPS
Segami Corporation
Radiology · 30d
Cleared Jan 13, 2005
ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
K043524 · IYN
B & K Medical A/S
Radiology · 24d
Cleared Jan 13, 2005
MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS
K043557 · EHD
Panoramic Corp.
Radiology · 17d
Cleared Jan 13, 2005
SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
K050034 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 6d
Cleared Jan 12, 2005
ODYSSEY
K042861 · MUJ
Permedics, Inc.
Radiology · 89d
Cleared Jan 12, 2005
GE SIGNA EXCITE MR SURGICAL OPTION
K043262 · LNH
Ge Healthcare
Radiology · 49d
Cleared Jan 12, 2005
SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
K043559 · IYN
Sonosite,Inc.
Radiology · 16d
Cleared Jan 11, 2005
VOXAR 3D PRODUCT FAMILY
K043194 · LLZ
Voxar Limited
Radiology · 54d
Cleared Jan 11, 2005
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K043563 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 15d
Cleared Jan 06, 2005
IMPLANT SCIENCES CORP, MODEL HDR-4140
K042864 · KXK
Implant Sciences Corp.
Radiology · 80d
Cleared Jan 06, 2005
MAMMOREPORT SOFTCOPY WORKSTATION
K042868 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 80d
Cleared Jan 06, 2005
ELITY 70 X-RAY
K043136 · EHD
Dental X-Ray E.U.
Radiology · 55d
Cleared Jan 06, 2005
CADSTREAM VERSION 4.0
K043216 · LLZ
Confirma, Inc.
Radiology · 45d
Cleared Jan 06, 2005
HD11 DIAGNOSTIC ULTRASOUND SYSTEM
K043535 · IYN
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Jan 05, 2005
IMT.LAB
K043360 · LLZ
Pie Medical
Radiology · 29d
Cleared Jan 04, 2005
HORIZON MEDICAL IMAGING
K043146 · LLZ
Mckesson Medical Imaging Company
Radiology · 50d
Cleared Dec 30, 2004
MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP...
K041125 · IWB
Masep Med Science & Tech. Development...
Radiology · 244d
Cleared Dec 30, 2004
CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K042221 · LLZ
Barco NV Barcoview
Radiology · 135d
Cleared Dec 23, 2004
SURGPLAN AND PANPLAN
K041078 · LLZ
Imaging Sciences Intl., Inc.
Radiology · 241d
Cleared Dec 23, 2004
SONATA 3-D IMAGING ACCESSORY, MODEL 3DS
K042620 · IYO
Tetrad Corp.
Radiology · 87d
Cleared Dec 23, 2004
SOMATOM RESPIRATORY GATING
K043086 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Dec 23, 2004
INFINIA LIGHTSPEED
K043381 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 14d
Cleared Dec 22, 2004
GE OEC FLUOROSTAR
K043076 · OWB
Ge Oec Medical Systems, Inc.
Radiology · 44d