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
10225–10248 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 24, 1998
ULTRASOUND WORKSTATION, UIWS-300A
K982976 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 90d
Cleared Nov 24, 1998
TUBING BLOOD FLOW METER MODEL NUMBER HD-800
K982986 · DPW
Koven Technology, Inc.
Radiology · 90d
Cleared Nov 23, 1998
MODEL 340GE-21C QUADRATURE BRAIN COIL
K982978 · MOS
Medical Advances, Inc.
Radiology · 90d
Cleared Nov 19, 1998
FACTS
K982010 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 164d
Cleared Nov 19, 1998
MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER
K982937 · LHN
Victoreen, Inc.
Radiology · 90d
Cleared Nov 18, 1998
FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS
K983262 · KGI
Lunar Corp.
Radiology · 62d
Cleared Nov 18, 1998
FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER
K983269 · KGI
Lunar Corp.
Radiology · 62d
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