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
10201–10224 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 18, 1998
FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS
K983271 · KGI
Lunar Corp.
Radiology · 62d
Cleared Nov 16, 1998
OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT...
K982610 · ITX
Olympus Optical, Co.
Radiology · 112d
Cleared Nov 16, 1998
FORTE
K982911 · KPS
Adac Laboratories
Radiology · 90d
Cleared Nov 16, 1998
SIGNA PROFILE SMALL HEAD COIL
K982972 · MOS
GE Medical Systems
Radiology · 83d
Cleared Nov 16, 1998
SKULL BASE INSTATRAK SYSTEM
K982994 · LLZ
Visualization Technology, Inc.
Radiology · 81d
Cleared Nov 16, 1998
XRAY VISION
K983111 · LLZ
Apteryx, Inc.
Radiology · 73d
Cleared Nov 16, 1998
MARK 5000 PHASED ARRAY SHOULDER COIL
K983143 · MOS
Usa Instruments, Inc.
Radiology · 69d
Cleared Nov 16, 1998
PLANMED SOPHIE & PLANNED SOPHIE CLASSIC
K983659 · IZH
Planmed OY
Radiology · 28d
Cleared Nov 13, 1998
FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000,...
K983028 · KGI
Hologic, Inc.
Radiology · 74d
Cleared Nov 12, 1998
PROFA
K981911 · IYE
Duncan Hynd Associates, Ltd.
Radiology · 164d
Cleared Nov 09, 1998
BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE...
K982840 · IYO
Boston Scientific Corp
Radiology · 89d
Cleared Nov 06, 1998
SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM
K983283 · MUH
Signet Radiology, Inc.
Radiology · 49d
Cleared Nov 05, 1998
MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7
K982821 · MUJ
Multimedia Medical Systems, Inc.
Radiology · 86d
Cleared Nov 04, 1998
CANON X-RAY DIGITAL CAMERA CXDI-11
K981556 · MQB
Canon USA, Inc.
Radiology · 187d
Cleared Nov 04, 1998
DIGIRAD 2020TC SPECT IMAGING SYSTEM
K982855 · KPS
Digirad Corp.
Radiology · 90d
Cleared Nov 04, 1998
HELAX-IMCON, VERSION 1.0
K982857 · KPQ
Helax AB
Radiology · 83d
Cleared Nov 04, 1998
SILHOUETTE VR
K982955 · KPR
GE Medical Systems
Radiology · 72d
Cleared Nov 04, 1998
CT BIOPSYVIEW
K983140 · JAK
Philips Medical Systems North...
Radiology · 57d
Cleared Nov 03, 1998
VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
K981886 · JAQ
Cook, Inc.
Radiology · 158d
Cleared Nov 03, 1998
MITRA IMAGING INC. EXHIBIT
K982769 · LLZ
Mitra Imaging, Inc.
Radiology · 88d
Cleared Nov 03, 1998
MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA
K982921 · MOS
Medrad, Inc.
Radiology · 76d
Cleared Nov 03, 1998
MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC
K982959 · LNH
Medrad, Inc.
Radiology · 71d
Cleared Nov 03, 1998
NEEDLE GUIDE
K983621 · IZH
Remington Medical, Inc.
Radiology · 19d
Cleared Nov 02, 1998
VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
K980576 · JAQ
Varian Medical Systems, Inc.
Radiology · 258d