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
10681–10704 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 22, 1997
DIASONICS ITNRAOPERATIVE PROBES
K961002 · ITX
Diasonics Ultrasound
Radiology · 316d
Cleared Jan 21, 1997
NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM
K962796 · IYN
Medasonics, Inc.
Radiology · 187d
Cleared Jan 17, 1997
DIGITAL IMAGE ANALYSIS SYSTEM
K962153 · LLZ
University of Washington
Radiology · 227d
Cleared Jan 17, 1997
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K964306 · LNH
General Electric Co.
Radiology · 80d
Cleared Jan 17, 1997
IPU RX-2
K964327 · LLZ
Medirex, Inc.
Radiology · 79d
Cleared Jan 17, 1997
XRT-7.0
K964583 · JAK
Elscint, Inc.
Radiology · 63d
Cleared Jan 17, 1997
DIGISCOPE RX-2 (9 OPTION)
K965013 · OXO
Medirex, Inc.
Radiology · 32d
Cleared Jan 10, 1997
VOLMETRIC COINCIDENCE DETECTION SYSTEM
K962100 · KPS
Elscint, Inc.
Radiology · 225d
Cleared Jan 10, 1997
PIXELL MRI SYSTEM
K962249 · LNH
General Medical Equipment Corp.
Radiology · 213d
Cleared Jan 10, 1997
VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
K964138 · KPQ
Varian Medical Systems, Inc.
Radiology · 87d
Cleared Jan 10, 1997
WRITESTAR, AND VIEWSTAR
K964274 · LMB
Comview Corp.
Radiology · 77d
Cleared Jan 10, 1997
PHILIPS TOMOSCAN AV EXPANDER UPGRADE
K964318 · JAK
Philips Medical Systems North...
Radiology · 73d
Cleared Jan 10, 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K964370 · LNH
GE Medical Systems
Radiology · 70d
Cleared Jan 10, 1997
PROFILE MAMMOGRAPHY SYSTEM (M-PRO)
K964576 · IZH
Bennett X-Ray Corp.
Radiology · 57d
Cleared Jan 07, 1997
GENIE PROCESSING AND REVIEW WORKSTATION
K964012 · KPS
GE Medical Systems
Radiology · 92d
Cleared Jan 03, 1997
RFA-300, LDA UTILITY
K961400 · IYE
Scanditronix Medical AB
Radiology · 267d
Cleared Jan 02, 1997
VINGMED SOUND COLOR FLOW MAPPING SYSTEM
K962662 · IYO
Diasonics, Inc.
Radiology · 178d
Cleared Jan 02, 1997
ACURAY DIGITAL X-RAY
K963403 · EHD
New Image Industries, Inc.
Radiology · 126d
Cleared Dec 23, 1996
SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A
K960948 · KPS
Toshiba Medical Systems
Radiology · 290d
Cleared Dec 23, 1996
H.A.M. APPLICATOR
K961601 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 242d
Cleared Dec 23, 1996
ULTRAMIX
K962093 · ITX
Sonotech, Inc.
Radiology · 208d
Cleared Dec 23, 1996
FLEXART V3.1 SOFTWARE
K962138 · LNH
Toshiba America Mri, Inc.
Radiology · 203d
Cleared Dec 23, 1996
ECOLOTION TRANSMISSION AND MASSAGE LOTION
K962840 · ITX
Eco-Med Pharmaceuticals, Inc.
Radiology · 168d
Cleared Dec 23, 1996
BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY
K963699 · EHD
Belmont Equipment Corp.
Radiology · 98d