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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,488 results
10081–10104 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 11, 1998
PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE
K983821 · LLZ
Philips Medical Systems North...
Radiology · 43d
Cleared Dec 11, 1998
FV-RF
K984111 · KPR
Philips Medical Systems (Cleveland),...
Radiology · 24d
Cleared Dec 11, 1998
MODIFICATION TO PROWESS PRO-SIM
K984196 · MUJ
Ssgi Prowess Systems
Radiology · 18d
Cleared Dec 11, 1998
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000
K984272 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 11d
Cleared Dec 11, 1998
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II
K984278 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 11d
Cleared Dec 10, 1998
INTERSOURCE
K973328 · KXK
International Brachytherapy S.A.
Radiology · 462d
Cleared Dec 08, 1998
PRODIGY TOTAL BODY SOFTWARE
K983564 · KGI
Lunar Corp.
Radiology · 56d
Cleared Dec 08, 1998
ORCA-DX BONE DENSITOMETER
K983724 · KGI
Lunar Corp.
Radiology · 47d
Cleared Dec 08, 1998
MAXVIEW DIAGNOSTIC WORKSTATION
K984023 · LLZ
Dynamic Healthcare Technologies, Inc.
Radiology · 26d
Cleared Dec 04, 1998
THERATRON ELITE
K983917 · IWB
Theratronics, Inc.
Radiology · 30d
Cleared Nov 24, 1998
PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE
K982536 · JAK
Siemens Corp.
Radiology · 126d
Cleared Nov 24, 1998
PHILIPS BUCKY VISION
K982795 · MQB
Philips Medical Systems, Inc.
Radiology · 106d
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