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
8377–8400 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 11, 2004
NEW BRID
K041780 · OWB
Medical Imaging Solutions, Inc.
Radiology · 41d
Cleared Aug 11, 2004
MARK III PHASED ARRAY SHOULDER COIL
K042009 · MOS
Usa Instruments, Inc.
Radiology · 16d
Cleared Aug 09, 2004
SECURVIEW DX SOFTCOPY WORKSTATION
K041555 · LLZ
Hologic, Inc.
Radiology · 60d
Cleared Aug 09, 2004
PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR
K041831 · MUH
Progeny, Inc.
Radiology · 33d
Cleared Aug 06, 2004
FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP
K041990 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 14d
Cleared Aug 04, 2004
ULTRABIO
K033178 · MUI
Sonotech, Inc.
Radiology · 308d
Cleared Aug 04, 2004
MODIFICATION TO: ON-BOARD IMAGER DEVICE
K041519 · IYE
Varian Medical Systems, Inc.
Radiology · 58d
Cleared Aug 04, 2004
HEMO-DOP
K041915 · IYN
Dwl Elektronische Systeme GmbH
Radiology · 19d
Cleared Jul 30, 2004
M'ATH STD
K040686 · LLZ
Intelligence IN Medical Technologies
Radiology · 136d
Cleared Jul 30, 2004
UNDECIDED
K041484 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 56d
Cleared Jul 30, 2004
ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM
K041916 · IYN
Aloka Co. Ltd USA
Radiology · 14d
Cleared Jul 30, 2004
ALLURA XPER FD10
K041949 · IZI
Philips Medical Systems North America...
Radiology · 10d
Cleared Jul 29, 2004
GEMINI PET/CT IMAGING SYSTEM
K041955 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 8d
Cleared Jul 28, 2004
GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR
K041922 · IZL
General Electric Co.
Radiology · 12d
Cleared Jul 27, 2004
ORTHO-CMS
K041162 · LLZ
Medis Medical Imaging Systems BV
Radiology · 85d
Cleared Jul 27, 2004
MEDCOMMONS OPEN RADIOLOGY GATEWAY
K041326 · LLZ
Medcommons, Inc.
Radiology · 70d
Cleared Jul 27, 2004
CAAS MRV
K041682 · LLZ
Pie Medical Imaging BV
Radiology · 36d
Cleared Jul 26, 2004
ECLIPSE WITH AAA
K041403 · MUJ
Varian Medical Systems
Radiology · 61d
Cleared Jul 26, 2004
PANORAMA 1.0T
K041602 · LNH
Philips Medical Systems North...
Radiology · 42d
Cleared Jul 26, 2004
GE SIGNA PROFILE 6 INCH GP COIL
K041921 · MOS
Ge Medical Systems, LLC
Radiology · 10d
Cleared Jul 23, 2004
TRIMED PLAN, VERSION 2.2
K031088 · MUJ
Trimed Systems, Inc.
Radiology · 476d
Cleared Jul 23, 2004
PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS
K041675 · IYN
Pie Medical
Radiology · 32d
Cleared Jul 23, 2004
LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE
K041695 · LNH
Usa Instruments, Inc.
Radiology · 31d
Cleared Jul 23, 2004
GE LOGIQ 7 ULTRASOUND BT04
K041813 · IYN
Ge Medical Systems Ultrasound and...
Radiology · 17d