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
9841–9864 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 07, 1999
BEACON-P, MODEL 211059
K992335 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 86d
Cleared Oct 07, 1999
EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS
K992450 · KPS
Emory University
Radiology · 77d
Cleared Oct 07, 1999
CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000
K992575 · LLZ
Infimed, Inc.
Radiology · 66d
Cleared Oct 07, 1999
TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)
K993038 · JAA
Toshiba America Medical Systems, In.C
Radiology · 27d
Cleared Oct 05, 1999
PREFERENCE TREATMENT SYSTEM
K983793 · LNH
Northwest Medical Physics Equipment,...
Radiology · 343d
Cleared Oct 04, 1999
INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM
K992262 · KXK
Indigo Medical, Inc.
Radiology · 90d
Cleared Oct 01, 1999
AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION
K992317 · KPS
Adac Laboratories
Radiology · 84d
Cleared Oct 01, 1999
OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500,...
K992775 · KGI
Hologic, Inc.
Radiology · 44d
Cleared Oct 01, 1999
SILHOUETTE FC
K993090 · KPR
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Sep 29, 1999
ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
K992352 · LMD
Inteleradiology, Inc.
Radiology · 77d
Cleared Sep 29, 1999
DIAGNOSTIC ULTRASOUND, MODEL 1.0
K992378 · IYO
Volumetrics Medical Imaging, Inc.
Radiology · 75d
Cleared Sep 28, 1999
ORTHOPANTOMOGRAPH OP100D
K992385 · MUH
Instrumentarium Corp.
Radiology · 74d
Cleared Sep 23, 1999
ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE,...
K990241 · LLZ
Accuimage Diagnostics Corp.
Radiology · 241d
Cleared Sep 23, 1999
PHOTON RADIOSURGERY SYSTEM (PRS)
K992577 · JAD
Photoelectron Corporation
Radiology · 52d
Cleared Sep 22, 1999
SAMSUNG RAYPAX DISPLAY WORKSTATION
K992306 · LLZ
Samsung Sds Co., Ltd.
Radiology · 75d
Cleared Sep 22, 1999
GE DIASONICS GATEWAY AND GATEWAY FX
K993069 · IYO
General Electric Co.
Radiology · 9d
Cleared Sep 21, 1999
RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS
K991319 · IYE
Orfit Industries
Radiology · 155d
Cleared Sep 21, 1999
I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401
K992963 · KXK
International Isotopes, Inc.
Radiology · 19d
Cleared Sep 16, 1999
STEPPING KINEMATIC IMAGING PLATFORM (SKIP)
K992892 · LNH
Magnetic Moments, LLC
Radiology · 20d
Cleared Sep 13, 1999
SAMSUNG RAYPAX LONG TERM ARCHIVE
K992131 · LMB
Samsung Sds Co., Ltd.
Radiology · 82d
Cleared Sep 09, 1999
PHILIPS EASYVISION WORKSTATION:
K990335 · LNH
Philips Medical Systems North...
Radiology · 218d
Cleared Sep 09, 1999
AX WORKSTATION
K992073 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 83d
Cleared Sep 09, 1999
SAMSUNG RAYPAX FILM DIGITIZER
K992112 · LLZ
Samsung Sds Co., Ltd.
Radiology · 79d
Cleared Sep 09, 1999
RENDER-PLAN 3-D
K992864 · MUJ
Precision Therapy Intl., Inc.
Radiology · 15d