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
8233–8256 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 21, 2004
TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM
K043452 · IYN
Sonosite,Inc.
Radiology · 6d
Cleared Dec 21, 2004
SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM
K043455 · IYN
Medison Co., Ltd.
Radiology · 6d
Cleared Dec 20, 2004
MODIFICATION TO: VIEWSTATION
K043412 · LLZ
Impac Medical Systems, Inc.
Radiology · 10d
Cleared Dec 17, 2004
MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U
K043293 · KPS
Acrorad Co., Ltd.
Radiology · 18d
Cleared Dec 17, 2004
CRANEX D
K043307 · EHD
Soredex Palodex Group OY
Radiology · 16d
Cleared Dec 15, 2004
DIRECT DIGITIZER, REGIUS MODEL 190
K042386 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 104d
Cleared Dec 15, 2004
SCENIUM
K042863 · KPS
Siemens Molecular Imaging, Ltd.
Radiology · 58d
Cleared Dec 15, 2004
SOMATOM CARE CONTRAST CT
K043087 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 37d
Cleared Dec 15, 2004
VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM
K043333 · LLZ
Vital Images, Inc.
Radiology · 12d
Cleared Dec 15, 2004
MISTAR, MODEL V3.2
K043350 · LLZ
Apollo Medical Imaging Technology...
Radiology · 9d
Cleared Dec 13, 2004
MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM
K043062 · IZL
Source-Ray, Inc.
Radiology · 38d
Cleared Dec 13, 2004
PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015
K043092 · EHD
Progeny, Inc.
Radiology · 34d
Cleared Dec 13, 2004
METRX WORKSTATION
K043134 · LLZ
Medical Metrx Solutions, Inc.
Radiology · 31d
Cleared Dec 13, 2004
TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES
K043278 · ITX
Teratech Corp.
Radiology · 17d
Cleared Dec 10, 2004
PALMSCAN AP2000
K043287 · IYO
Micromedical Devices, Inc.
Radiology · 11d
Cleared Dec 09, 2004
MAGNETOM C! MR SYSTEM
K043030 · LNH
Siemens Medical Solutions
Radiology · 36d
Cleared Dec 09, 2004
BEST RADIOPAQUE STRAND
K043117 · KXK
Best Medical International, Inc.
Radiology · 29d
Cleared Dec 09, 2004
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER
K043275 · IYO
Olympus Medical Systems Corporation
Radiology · 13d
Cleared Dec 03, 2004
ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER...
K041834 · MUH
Takara Belmont USA, Inc.
Radiology · 149d
Cleared Dec 03, 2004
SHIMADZU COLLIMATOR R-20J
K042840 · IZX
Shimadzu Corp.
Radiology · 50d
Cleared Nov 30, 2004
ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM
K043196 · IYN
Aloka Co., Ltd.
Radiology · 12d
Cleared Nov 24, 2004
DRY LASER IMAGER, MODEL DRYPRO MODEL 793
K042133 · LMC
Konica Minolta Medical & Graphic, Inc.
Radiology · 107d
Cleared Nov 24, 2004
AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS
K042353 · LLZ
National Display Systems
Radiology · 86d
Cleared Nov 24, 2004
X-LEONARDO
K042995 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 23d