FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,488 results
10585–10608 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 20, 1997
NDC DENTAL SYSTEM, VERSION 1.5 X-RAY AND VIDEO
K971714 · LLZ
National Data Corp.
Radiology · 42d
Cleared Jun 16, 1997
GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO....
K965044 · LNH
Elscint, Inc.
Radiology · 185d
Cleared Jun 13, 1997
BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
K961787 · KGI
Hologic, Inc.
Radiology · 400d
Cleared Jun 13, 1997
MITAYA ALUMINUM INTERSPACED X-RAY GRID
K964025 · IXJ
X-Ray Accessory Corp.
Radiology · 249d
Cleared Jun 13, 1997
VERIDOSE DIODES
K964785 · IYE
Victoreen, Inc.
Radiology · 196d
Cleared Jun 13, 1997
MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM
K970964 · LLZ
International Imaging Electronics
Radiology · 88d
Cleared Jun 13, 1997
CARDIOMATCH
K970970 · KPS
Focus Medical SA
Radiology · 88d
Cleared Jun 13, 1997
AUTIMO
K971001 · IXI
Medizintechnik, GmbH
Radiology · 86d
Cleared Jun 13, 1997
OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS
K971054 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 81d
Cleared Jun 13, 1997
THERAPAX SXT 150
K971074 · JAD
Pantak, Inc.
Radiology · 81d
Cleared Jun 13, 1997
GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE
K971115 · ITX
Protek Medical Products, Inc.
Radiology · 78d
Cleared Jun 06, 1997
MODEL HNC NEUROVASCULAR ARRAY COIL
K970868 · MOS
Mri Devices Corp.
Radiology · 88d
Cleared Jun 06, 1997
MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)
K971016 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 78d
Cleared Jun 06, 1997
PRONE BREAST POSITIONING BOARD, MODEL #37-018
K971382 · IYE
Victoreen, Inc.
Radiology · 84d
Cleared Jun 05, 1997
MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE)
K970852 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Jun 03, 1997
ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER
K964549 · ITX
Aloka Co., Ltd.
Radiology · 202d
Cleared May 29, 1997
HR12000 ULTRASOUND SYSTEM
K961229 · IYO
International Ultrasound Corp.
Radiology · 426d
Cleared May 29, 1997
SONOLINE VERSA 555 DIAGNOSTIC ULTRASOUND SYSTEM
K962142 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 360d
Cleared May 29, 1997
CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS
K963065 · IYO
Shantou Institute of Ultrasonic...
Radiology · 295d
Cleared May 29, 1997
CTS-200 WITH EZU-PL21 TRANSDUCER
K963068 · IYO
Shantou Institute of Ultrasonic...
Radiology · 295d
Cleared May 29, 1997
GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES
K963990 · LNH
Philips Medical Systems, Inc.
Radiology · 237d
Cleared May 29, 1997
511 KEV COLLIMATOR
K964438 · KPS
Trionix Research Laboratory, Inc.
Radiology · 205d
Cleared May 29, 1997
CARDIAC SCORING FOR CT SCANNERS
K970980 · JAK
Elscint, Inc.
Radiology · 72d
Cleared May 28, 1997
NOTEBOOK IMAGER
K961104 · IYX
Digirad Corp.
Radiology · 434d