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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
11569–11592 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 30, 1994
ROYAL MARSDEN GOLD GRAIN GUN
K940119 · IWS
Best Industries
Radiology · 354d
Cleared Dec 30, 1994
IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS
K940121 · IWJ
Best Industries
Radiology · 354d
Cleared Dec 30, 1994
2D,3D, TOF MR ANGIOGRAPHY
K943800 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 149d
Cleared Dec 29, 1994
SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM
K943637 · ITX
Aloka Co., Ltd.
Radiology · 155d
Cleared Dec 29, 1994
NEEDLE GUIDE
K943863 · IYN
Biopsys Medical, Inc.
Radiology · 143d
Cleared Dec 27, 1994
AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM
K923273 · IYO
Acoustic Imaging Technologies Corp.
Radiology · 904d
Cleared Dec 27, 1994
MEDISON 4800
K925582 · IYO
Medison America, Inc.
Radiology · 782d
Cleared Dec 27, 1994
VISUALIZER 2000
K943272 · JAA
Vf-Works, Inc.
Radiology · 173d
Cleared Dec 27, 1994
MAMMOGRAPHIC X-RAY UNIT
K945496 · IZH
Lorad Corp.
Radiology · 49d
Cleared Dec 27, 1994
KXO-80G
K945668 · IZO
Toshiba America Medical Systems, In.C
Radiology · 40d
Cleared Dec 23, 1994
SUPERSENSOR MRI COIL
K941582 · LNH
Superconductor Technologies, Inc.
Radiology · 267d
Cleared Dec 23, 1994
FUJI FCR IMAGE PROCESSING UNIT IP-U515
K942561 · IXK
Fujifilm Medical System U.S.A., Inc.
Radiology · 206d
Cleared Dec 23, 1994
SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR
K942613 · DPW
Koven Technology, Inc.
Radiology · 204d
Cleared Dec 23, 1994
TUNGSTEN EYESHIELD
K943011 · IWS
Medtec, Inc.
Radiology · 182d
Cleared Dec 23, 1994
FIELD ABUTMENT WEDGE
K943343 · IXI
Medtec, Inc.
Radiology · 164d
Cleared Dec 23, 1994
RIT 531 TELERADIOLOGY/ PAC SYSTEM
K944130 · LMD
Radiological Imaging Technology, Inc.
Radiology · 121d
Cleared Dec 23, 1994
COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION
K944720 · KPS
Nuccardiac Software, Inc.
Radiology · 91d
Cleared Dec 22, 1994
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K944112 · LNH
GE Medical Systems
Radiology · 121d
Cleared Dec 15, 1994
UNITONE
K934572 · LLZ
Scitex Corporation , Ltd.
Radiology · 450d
Cleared Dec 15, 1994
RF DRIVER, RADIO FREQUENCY DRIVER
K943406 · IYE
Pro-Comm, Inc.
Radiology · 154d
Cleared Dec 15, 1994
MERIT (O.1T MR SYSTEM)
K943415 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 153d
Cleared Dec 15, 1994
HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER
K944523 · IYO
Humphrey, Inc.
Radiology · 90d
Cleared Dec 15, 1994
MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268,...
K945238 · IWQ
F. Walter Hanel GmbH
Radiology · 49d
Cleared Dec 14, 1994
NRF SYSTEM
K944973 · JAA
Philips Medical Systems (Cleveland),...
Radiology · 64d