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
11977–12000 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 01, 1993
ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY
K930960 · LNH
Toshiba America Mri, Inc.
Radiology · 250d
Cleared Nov 01, 1993
VISIONLINK INTERFILE CONVERSION SOFTWARE
K933372 · KPS
Evergreen Technologies, Inc.
Radiology · 115d
Cleared Nov 01, 1993
PICTURE ARCHIVING & COMMUNICATIONS SYSTEMS(PACS)
K933446 · KPS
Sudbury Systems, Inc.
Radiology · 111d
Cleared Oct 29, 1993
FAN BEAM COLLIMATOR
K933256 · IYX
Siemens Gammasonics, Inc.
Radiology · 115d
Cleared Oct 28, 1993
PHILIPS MRI BREAST COIL
K926275 · LNH
Philips Medical Systems, Inc.
Radiology · 318d
Cleared Oct 25, 1993
CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY
K926252 · IYO
Endosonics Corp.
Radiology · 315d
Cleared Oct 25, 1993
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K932344 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 164d
Cleared Oct 12, 1993
P/METER
K921377 · DPW
Zertl Medical, Inc.
Radiology · 567d
Cleared Oct 08, 1993
ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT
K925627 · IYO
Elscint, Inc.
Radiology · 336d
Cleared Oct 08, 1993
MRT-50A, MRT-150A
K926001 · LNH
Toshiba America Mri, Inc.
Radiology · 315d
Cleared Oct 08, 1993
AZ 92
K931974 · IWE
A2j, Inc.
Radiology · 169d
Cleared Oct 08, 1993
BCM-600TX
K933035 · KPX
B C Medical , Ltd.
Radiology · 108d
Cleared Oct 07, 1993
MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE
K925286 · LNH
Toshiba America Mri, Inc.
Radiology · 352d
Cleared Oct 07, 1993
SNR-3000 UPGRADE RECEIVER COILS
K925597 · LNH
Magnetic Resonance Plus, Inc.
Radiology · 337d
Cleared Oct 07, 1993
GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0
K925985 · LNH
Elscint, Inc.
Radiology · 316d
Cleared Oct 07, 1993
MRINNERVU DISPOSABLE ENDORECTAL CERVIX COIL#BCR-15
K930779 · LNH
Medrad, Inc.
Radiology · 233d
Cleared Oct 07, 1993
ARTOSCAN
K931022 · LNH
Biosound, Inc.
Radiology · 220d
Cleared Oct 07, 1993
EDGE SYSTEM
K932693 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 126d
Cleared Oct 07, 1993
SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER
K932777 · ITX
Peripheral Systems Group
Radiology · 121d
Cleared Oct 07, 1993
HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE
K933073 · IZI
Heartware Intl. Corp.
Radiology · 106d
Cleared Oct 07, 1993
LUMISCAN 50
K933129 · LMA
Lumisys, Inc.
Radiology · 101d
Cleared Oct 07, 1993
SPECTRUM DG-P7000 PEDIATRIC CRADLE
K933134 · KXH
Spectrum X-Ray Corp.
Radiology · 101d
Cleared Oct 07, 1993
ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN
K933161 · EAM
Dupont Medical Products
Radiology · 100d
Cleared Oct 07, 1993
MRX-750
K933162 · ITY
Mrx Corp.
Radiology · 100d