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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,668 results
11233–11256 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 17, 1996
ALOKA OMNIVIEW DIAGNOSTIC ULTRASOUND SYSTEM
K954022 · IYN
Aloka Co., Ltd.
Radiology · 142d
Cleared Jan 05, 1996
HOLOPSY SYSTEM
K951999 · IYO
Neovision Corp.
Radiology · 252d
Cleared Jan 05, 1996
SIEMENS VIRTURAL WEDGE
K954248 · IXI
Siemens Medical Solutions USA, Inc.
Radiology · 116d
Cleared Jan 05, 1996
CLARK TUT IMAGE PROCESSING SYSTEM
K954589 · LLZ
Clark Research and Development, Inc.
Radiology · 94d
Cleared Jan 05, 1996
PRO VISION
K954678 · LLZ
Algotec Systems, Ltd.
Radiology · 87d
Cleared Jan 05, 1996
ACRYSTEEL BLOCKING TRAY
K954705 · IYE
Medtec, Inc.
Radiology · 85d
Cleared Jan 03, 1996
GE ADVANTAGE DICOM CR REPROCESSING STATION
K955185 · LLZ
GE Medical Systems
Radiology · 51d
Cleared Jan 02, 1996
ASPECT ACQUISITION MODULE (AAM)
K954875 · LMA
Aspect Electronics, Inc.
Radiology · 70d
Cleared Dec 28, 1995
ATLANTIS
K953936 · EAP
Trophy Radiologie
Radiology · 129d
Cleared Dec 22, 1995
SSA-340A
K941352 · IYN
Toshiba America Medical Systems, In.C
Radiology · 641d
Cleared Dec 22, 1995
GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
K945945 · LNH
Philips Medical Systems North...
Radiology · 382d
Cleared Dec 22, 1995
COBRASCAN CX-312
K953942 · LMA
Radiographic Digital Imaging, Inc.
Radiology · 141d
Cleared Dec 22, 1995
SPECTRADIGITAL SERIES V250DSP
K954129 · KPS
Hitachi Medical Corp. of America
Radiology · 112d
Cleared Dec 22, 1995
HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS
K954143 · KPS
Hitachi Medical Corp. of America
Radiology · 112d
Cleared Dec 22, 1995
RADIOSURGERY VERIFICATION PHANTOM
K954634 · IYE
The Phantom Laboratory, Inc.
Radiology · 77d
Cleared Dec 22, 1995
MOBILE X-RAY SYSTEM
K955036 · IZL
Shimadzu Corp.
Radiology · 49d
Cleared Dec 22, 1995
SENSOR PAD
K955249 · IZH
Inventive Products, Inc.
Radiology · 37d
Cleared Dec 21, 1995
ALDERSON BREST DOSIMETRY SYSTEM
K946074 · IYE
Radiology Support Devices, Inc.
Radiology · 387d
Cleared Dec 21, 1995
EXL-15DP & 20-DP LINAC
K952108 · IYE
Mitsubishi Intl. Corp.
Radiology · 230d
Cleared Dec 21, 1995
THERMOPLASTIC SHIELD
K954456 · KPY
Medtec, Inc.
Radiology · 87d
Cleared Dec 21, 1995
ARC SERIES
K954581 · IZI
Continental X-Ray Corp.
Radiology · 80d
Cleared Dec 21, 1995
ECHONET
K954860 · LLZ
Heartlab, Inc.
Radiology · 59d
Cleared Dec 21, 1995
SIERRA BATTERY SEALED LEAD ACID BATTERY SYSTEM
K955095 · IZL
Sierra Battery, Inc.
Radiology · 44d
Cleared Dec 11, 1995
ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM
K944612 · LLZ
Codman & Shurtleff, Inc.
Radiology · 448d