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
8521–8544 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 07, 2004
MODIFICATION TO GE DISCOVERY LS SYSTEM
K040172 · KPS
GE Medical Systems
Radiology · 72d
Cleared Apr 07, 2004
CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM
K040195 · LLZ
Witt Biomedical Corp
Radiology · 70d
Cleared Apr 07, 2004
TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY
K040556 · EHD
Eastman Kodak Company
Radiology · 36d
Cleared Apr 06, 2004
CADIMPLANT
K040224 · JAK
Praxim, Inc.
Radiology · 64d
Cleared Apr 05, 2004
DYNATRAC, COD. 50-1A
K034051 · IYE
3D Line USA, Inc.
Radiology · 97d
Cleared Apr 02, 2004
THE CARDIOP-B SYSTEM
K030139 · IZI
Paieon, Inc.
Radiology · 444d
Cleared Apr 02, 2004
SOMATOM SENSATION 64 AND SENSATION CARDIAC
K040665 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Apr 01, 2004
X-VIEW
K024186 · MUH
Sometech Corporation
Radiology · 469d
Cleared Apr 01, 2004
MODIFICATION TO ACCULEAF
K040553 · IXI
Direx Systems Corp.
Radiology · 30d
Cleared Mar 31, 2004
ULTRASOUND IMAGING SYSTEM, MODEL 7300
K040596 · IYN
Esaote, S.P.A.
Radiology · 23d
Cleared Mar 29, 2004
NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM
K040040 · LLZ
Barco NV Barcoview
Radiology · 80d
Cleared Mar 29, 2004
NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM
K040041 · LLZ
Barco NV Barcoview
Radiology · 80d
Cleared Mar 29, 2004
QONTRAST
K040399 · LLZ
Amid
Radiology · 41d
Cleared Mar 26, 2004
ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D...
K040719 · IYO
Aloka Co., Ltd.
Radiology · 7d
Cleared Mar 24, 2004
INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500
K040050 · LLZ
Ge Medical Systems Navigation and...
Radiology · 72d
Cleared Mar 24, 2004
CARDIOMD-AC
K040616 · KPS
Danish Diagnostic Development A/S
Radiology · 15d
Cleared Mar 22, 2004
MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER
K040541 · JAQ
Varian Medical Systems, Inc.
Radiology · 20d
Cleared Mar 22, 2004
SOMATOM PROJECT P30L
K040577 · JAK
Siemens Medical Systems, Inc.
Radiology · 18d
Cleared Mar 22, 2004
MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL
K040640 · MOS
Igc-Medical Advances, Inc.
Radiology · 12d
Cleared Mar 17, 2004
CAAS II RVA
K033920 · LLZ
Pie Medical Imaging BV
Radiology · 90d
Cleared Mar 17, 2004
RTIST
K033955 · LLZ
Mirada Solutions , Ltd.
Radiology · 86d
Cleared Mar 17, 2004
NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM
K040039 · LLZ
Barco N.V.
Radiology · 68d
Cleared Mar 11, 2004
WBR-FHR, WBR-FWB
K040370 · KPS
Ultraspect , Ltd.
Radiology · 27d
Cleared Mar 11, 2004
MEDIPACS
K040486 · LLZ
Neobit Co., Ltd.
Radiology · 15d