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
10777–10800 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared May 28, 1997
THERATON 1000E
K964607 · IWD
Theratronics, Inc.
Radiology · 191d
Cleared May 20, 1997
OUR ROTATING GAMMA SYSTEM
K970647 · IWB
Our Scientific Intl., Inc.
Radiology · 89d
Cleared May 20, 1997
HOWTEK 960
K970908 · LMA
Howtek, Inc.
Radiology · 70d
Cleared May 20, 1997
SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR
K970999 · JAK
Sony Medical Systems
Radiology · 62d
Cleared May 20, 1997
UMI X-RAY FILM CASSETTE
K971431 · IXA
Umi Intl.
Radiology · 33d
Cleared May 14, 1997
SCANRITE DFS
K970850 · EHD
Scanrite Systems
Radiology · 68d
Cleared May 14, 1997
B-350 CEILING MOUNTED C-POSITIONER
K970947 · JAA
Omega Medical Imaging, Inc.
Radiology · 61d
Cleared May 14, 1997
PHILIPS INTEGRIS H5000
K971365 · IZI
Philips Medical Systems North...
Radiology · 30d
Cleared May 14, 1997
MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE
K971452 · IZZ
Siemens Medical Solutions USA, Inc.
Radiology · 23d
Cleared May 12, 1997
DYNAMIC WEDGE
K970564 · IYE
Mitsubishi Electronics America, Inc.
Radiology · 88d
Cleared May 12, 1997
BRAINLAB MICRO MULTI-LEAF COLLIMATOR
K970586 · IYE
Brainlab Med. Computersysteme GmbH
Radiology · 87d
Cleared May 12, 1997
GE ADVANTAGE DIGITIZER WORKSTATION
K970628 · LMD
Ge Medical Systems, Inc.
Radiology · 82d