FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
8689–8712 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 03, 2003
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
K030110 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 80d
Cleared Apr 01, 2003
SUPEROPEN 0.35T, MODEL NSM-P035
K030918 · LNH
Neusoft Digital Medical Systems Co.,...
Radiology · 8d
Cleared Mar 28, 2003
SEEDLINKS, MODELS 70301, 70302, 70303
K023210 · KXK
Sourcetech Medical, LLC
Radiology · 183d
Cleared Mar 28, 2003
LAWRENCE CSERION, MODEL CS-1
K030162 · KXK
Isoray, Inc.
Radiology · 71d
Cleared Mar 28, 2003
THE OBSIDIAN PACS SYSTEM
K030635 · LLZ
Obsidian Medical Technology, Inc.
Radiology · 28d
Cleared Mar 28, 2003
GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
K030874 · LNH
General Electric Co.
Radiology · 8d
Cleared Mar 27, 2003
ORG@NIZER, MODEL VERSION 3.0
K030363 · LLZ
Ebit Sanita, S.P.A.
Radiology · 51d
Cleared Mar 27, 2003
OTI SCAN WITH TRANSDUCERS
K030770 · IYO
Ophthalmic Technologies, Inc.
Radiology · 16d
Cleared Mar 26, 2003
MHS 7000
K030018 · LHQ
Micro Health Systems, Inc.
Radiology · 83d
Cleared Mar 26, 2003
DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM
K030763 · IYO
Diagnostic Ultrasound Corp.
Radiology · 15d
Cleared Mar 25, 2003
20.1 MONOCHROME LCD MONITOR, RADIFORCE G21
K024358 · LLZ
Eizo Nanao Corporation
Radiology · 85d
Cleared Mar 25, 2003
MODEL 1300GE-64: PEDIATRIC POSITIONER
K030317 · MOS
Midwest Rf, LLC
Radiology · 54d
Cleared Mar 25, 2003
MULTICARE PLATINUM SYSTEM AND ACCESSORIES
K030666 · IZH
Lorad, A Hologic Co.
Radiology · 22d
Cleared Mar 21, 2003
POD PAC-20M
K030610 · IYO
Portable Ophthalmic Devices, Inc.
Radiology · 23d
Cleared Mar 20, 2003
OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
K024012 · JAA
Ge Oec Medical Systems
Radiology · 106d
Cleared Mar 20, 2003
EVA DIGITAL DENTAL X-RAY SYSTEM
K030647 · EHD
Afp Imaging Corp.
Radiology · 20d
Cleared Mar 17, 2003
ALTON PT STEPPER
K024183 · KXK
Alton Design, LLC
Radiology · 88d
Cleared Mar 17, 2003
MODULEAF
K030609 · IXI
Mrc Systems GmbH
Radiology · 19d
Cleared Mar 13, 2003
BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM
K030455 · IYN
Philips Ultrasound, Inc.
Radiology · 30d
Cleared Mar 12, 2003
GAMMAMED 212 AND 232 SOURCE ASSEMBLY
K030745 · KXK
Varian Medical Systems
Radiology · 2d
Cleared Mar 11, 2003
OPTIDOS
K010705 · KXK
Ptw-New York Corp.
Radiology · 732d
Cleared Mar 11, 2003
CCD CAMERA, MODEL PKP-06000-000
K024085 · IZJ
Perkins Electronics Co.
Radiology · 90d
Cleared Mar 11, 2003
VICTOREEN THEBES II, MODEL 7020
K024284 · IYE
Syncor Radiation Management
Radiology · 78d
Cleared Mar 11, 2003
ENDOS AC/ACP
K030185 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 49d