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
8281–8304 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 10, 2004
ACCUPACH V
K042752 · IYO
Accutome Ultrasound, Inc.
Radiology · 37d
Cleared Nov 10, 2004
TRAUMACAD 1.2
K042816 · LLZ
Orthocrat, Ltd.
Radiology · 29d
Cleared Nov 09, 2004
GEMINI GXL
K042935 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 15d
Cleared Nov 08, 2004
SUPERDIMENSION/BRONCHUS
K042438 · JAK
Superdimension, Ltd.
Radiology · 61d
Cleared Nov 08, 2004
IMAGE MEDICAL ACQUISITION STATION (IMAS)
K042700 · LLZ
Erad Imagemedical Corp.
Radiology · 39d
Cleared Nov 05, 2004
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
K042617 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 42d
Cleared Nov 05, 2004
ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING...
K042619 · MUI
Sonotech, Inc.
Radiology · 42d
Cleared Nov 03, 2004
BEST BREAST BRACHYTHERAPY APPLICATOR
K042586 · JAQ
Best Medical International, Inc.
Radiology · 42d
Cleared Nov 03, 2004
HI-ART SYSTEM
K042739 · MUJ
Tomotherapy Incorporated
Radiology · 30d
Cleared Nov 03, 2004
GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6...
K042844 · MOS
Ge Medical Systems, Inc.
Radiology · 19d
Cleared Nov 03, 2004
JETSTREAM WORKSPACE
K042880 · KPS
Adac Laboratories
Radiology · 15d
Cleared Nov 03, 2004
I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM
K042948 · LNH
Wandong Medical
Radiology · 8d
Cleared Nov 02, 2004
AMX5 AND AMX5D MOBILE X-RAY SYSTEMS
K042866 · IZL
Ge Healthcare Technologies
Radiology · 15d
Cleared Nov 02, 2004
PHILIPS ORTHOPAEDIC APPLICATIONS
K042867 · LLZ
Philips Medical Systems North...
Radiology · 15d
Cleared Oct 29, 2004
MAMMOTEST
K042095 · IZH
Fischer Imaging Corp.
Radiology · 87d
Cleared Oct 29, 2004
INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
K042480 · KGI
Hologic, Inc.
Radiology · 46d
Cleared Oct 29, 2004
ON-BOARD IMAGER DEVICE
K042720 · IYE
Varian Medical Systems
Radiology · 28d
Cleared Oct 29, 2004
ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)
K042793 · OWB
Siemens Medi Cal Solutions, Inc.
Radiology · 22d
Cleared Oct 29, 2004
C-PET PLUS IMAGING SYSTEM
K042839 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 15d
Cleared Oct 29, 2004
AUTOSPECS
K042903 · KPS
Adac Laboratories
Radiology · 14d
Cleared Oct 28, 2004
ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER)
K042831 · IYO
Reichert, Inc.
Radiology · 15d
Cleared Oct 28, 2004
SIENET COSMOS (VERSION V15A)
K042832 · LLZ
Siemens AG Medical Solutions
Radiology · 15d
Cleared Oct 27, 2004
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
K042833 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Oct 22, 2004
UNFORS PATIENT SKIN DOSIMETER (PSD)
K042698 · JAA
Unfors, Inc.
Radiology · 22d