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
10009–10032 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 01, 1999
DIGITAL IMAGING SYSTEM (BSR)
K991922 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 86d
Cleared Sep 01, 1999
VANTAGE EXSPECT II
K992078 · KPS
Adac Laboratories
Radiology · 75d
Cleared Sep 01, 1999
C-QUEST
K992103 · OWB
Wuestec Medical, Inc.
Radiology · 71d
Cleared Sep 01, 1999
SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM
K992761 · IYO
Medison America, Inc.
Radiology · 15d
Cleared Sep 01, 1999
OPTIMAX/ COMPACT 2
K992818 · IXW
Protec GmbH & Co. KG
Radiology · 12d
Cleared Aug 30, 1999
XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL
K991237 · MUJ
Radionics, Inc.
Radiology · 140d
Cleared Aug 30, 1999
REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM
K992066 · KPR
GE Medical Systems
Radiology · 73d
Cleared Aug 27, 1999
IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER
K982208 · ITX
Jomed Imaging , Ltd.
Radiology · 430d
Cleared Aug 26, 1999
HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
K991841 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 90d
Cleared Aug 24, 1999
ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM
K992663 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared Aug 23, 1999
MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA
K991896 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 81d
Cleared Aug 23, 1999
MRGP OPTICAL TRACKING UNIT
K991943 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 75d
Cleared Aug 23, 1999
ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM
K992470 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 28d
Cleared Aug 23, 1999
SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
K992644 · MUH
Sirona Dental Systems GmbH
Radiology · 17d
Cleared Aug 19, 1999
MINI 6800 DIGITAL MOBILE C-ARM
K992506 · OXO
Ge Dec Medical Systems
Radiology · 23d
Cleared Aug 17, 1999
KONICA DIRECT DIGITIZER, MODEL DD-341
K990359 · MQB
Konica Corp.
Radiology · 193d
Cleared Aug 17, 1999
SOMATOM PROJECT 10-CT SCANNERS
K991764 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 85d
Cleared Aug 17, 1999
GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE...
K992152 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 53d
Cleared Aug 17, 1999
IPASS BOLUS TRACKING
K992412 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 28d
Cleared Aug 13, 1999
DIGITAL VIDEO RECORDING SYSTEM
K991738 · LLZ
Kay Elemetrics Corp.
Radiology · 84d
Cleared Aug 13, 1999
EXPLORER 3D
K991815 · MUJ
Our Scientific Intl., Inc.
Radiology · 78d
Cleared Aug 13, 1999
SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM
K992046 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Aug 13, 1999
DYNAWELL OR DYNAWELL
K992120 · LNH
Ekeroth Quality AB
Radiology · 51d
Cleared Aug 10, 1999
ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A
K991766 · JAK
Toshiba America Medical Systems, In.C
Radiology · 78d