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
10201–10224 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 23, 1998
TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A
K983516 · KPS
Toshiba America Medical Systems, In.C
Radiology · 77d
Cleared Dec 21, 1998
INSIGHT DIAGNOSTIC IMAGING WORKSTATION
K982535 · LLZ
Neo Imagery Technologies, Inc.
Radiology · 154d
Cleared Dec 21, 1998
MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE
K983342 · LHN
Philips Medical Systems (Cleveland),...
Radiology · 89d
Cleared Dec 21, 1998
PHILIPS INTEGRIS 3D RA OPTION
K983877 · IZI
Philips Medical Systems North...
Radiology · 49d
Cleared Dec 15, 1998
ELECTRON WEDGE MODEL MT-EW-1000
K981992 · IXI
Med-Tec,Inc.
Radiology · 190d
Cleared Dec 15, 1998
ADVANTAGE WINDOWS (AW) FUSION
K983256 · LLZ
GE Medical Systems
Radiology · 90d
Cleared Dec 15, 1998
DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR
K983392 · LLZ
Data Ray
Radiology · 81d
Cleared Dec 15, 1998
FRAMEWAVE WEB
K983401 · LLZ
Ml Strategies, Inc.
Radiology · 78d
Cleared Dec 11, 1998
STRATA, MODEL V.O.95
K981678 · MUJ
Rosses Medical Systems
Radiology · 213d
Cleared Dec 11, 1998
OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR...
K982323 · ITX
Olympus America, Inc.
Radiology · 162d
Cleared Dec 11, 1998
CDR - PAN MODEL 4700
K982661 · MQB
Schick Technologies, Inc.
Radiology · 134d
Cleared Dec 11, 1998
ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
K983313 · IZH
Elscint, Inc.
Radiology · 81d
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