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
9937–9960 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 13, 1999
VIDEO PLUS SYSTEM, SERIES 95000
K992666 · LLZ
Camtronics, Ltd.
Radiology · 65d
Cleared Oct 12, 1999
SNT IMAGE ANALYSIS SYSTEM
K992354 · LLZ
Surgical Navigation Technologies, Inc.
Radiology · 90d
Cleared Oct 08, 1999
VIRGO MRI SYSTEM
K990153 · LNH
Millennium Technology Services
Radiology · 262d
Cleared Oct 08, 1999
AIRIS, AIRIS II
K992650 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 63d
Cleared Oct 07, 1999
CET PROSTATE APPLICATOR SET, PART NUMBER 089.066
K990990 · JAQ
Nucletron Corp.
Radiology · 197d
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