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
7825–7848 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 31, 2006
KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386
K060550 · KPR
Eastman Kodak Company
Radiology · 29d
Cleared Mar 31, 2006
1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL
K060689 · MOS
Resonance Innovations, LLC
Radiology · 16d
Cleared Mar 31, 2006
SINMED POSITIONING DEVICES
K060737 · IYE
Sinmed BV
Radiology · 11d
Cleared Mar 29, 2006
ACCU-SOURCE
K051753 · JAQ
Oncology Systems, Inc.
Radiology · 273d
Cleared Mar 29, 2006
INNOCURE IMRT FILTER (COMPENSATORS)
K052383 · IXI
Innocure, LLC
Radiology · 211d
Cleared Mar 29, 2006
O-ARM IMAGING SYSTEM
K060344 · OXO
Breakaway Imaging, LLC
Radiology · 47d
Cleared Mar 29, 2006
VOXAR 3D ENTERPRISE, MODEL 6.1
K060505 · LLZ
Barcoview Mis Edinburgh
Radiology · 30d
Cleared Mar 29, 2006
ACCESS BREAST COIL 4/SMS
K060547 · MOS
Confirma, Inc.
Radiology · 28d
Cleared Mar 23, 2006
CYCLONE, MODEL MAICAM 180
K060486 · KPS
Spectrica
Radiology · 27d
Cleared Mar 22, 2006
M-VU VIEWER STATION
K060451 · LLZ
Vucomp, Inc.
Radiology · 29d
Cleared Mar 17, 2006
VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE
K060267 · LLZ
Implant Logic Systems, Ltd.
Radiology · 44d
Cleared Mar 17, 2006
EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8
K060475 · ODB
Olympus Medical Systems Corporation
Radiology · 22d
Cleared Mar 17, 2006
BIOGRAPH 64 AND BIOGRAPH 40
K060631 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 8d
Cleared Mar 16, 2006
EMD THERMOGRAPHY SYSTEM
K050239 · LHQ
Em Diagnostics, Inc.
Radiology · 407d
Cleared Mar 16, 2006
KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
K060137 · MQB
Eastman Kodak Company
Radiology · 56d
Cleared Mar 16, 2006
CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER
K060440 · LMC
Codonics, Inc.
Radiology · 23d
Cleared Mar 15, 2006
ONCOR EXPRESSION
K060226 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 44d
Cleared Mar 15, 2006
IQPACS
K060263 · LLZ
S.C. Info World S.R.L.
Radiology · 42d
Cleared Mar 15, 2006
PLANMECA PROMAX 3D
K060328 · MUH
Planmeca Oy
Radiology · 34d
Cleared Mar 15, 2006
MEDRAD 3.0T ECOIL IMAGING SYSTEM
K060401 · MOS
Medrad, Inc.
Radiology · 28d
Cleared Mar 10, 2006
MIGUE
K052212 · IYE
Direx Systems Corp.
Radiology · 207d
Cleared Mar 10, 2006
CT PERFUSION 4
K052839 · JAK
Ge Healthcare
Radiology · 154d
Cleared Mar 10, 2006
VIX WIN PRO
K060178 · MUH
Gendex Dental Systems
Radiology · 46d
Cleared Mar 10, 2006
PROGUIDE NEEDLE SET
K060349 · JAQ
Nucletron Corporation
Radiology · 28d