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
7969–7992 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 07, 2005
AJEX 9015/135H PORTABLE X-RAY
K052341 · IZL
Jpi America, Inc.
Radiology · 42d
Cleared Oct 07, 2005
1.5T 12 CHANNEL BODY ARRAY
K052584 · MOS
Usa Instruments, Inc.
Radiology · 17d
Cleared Oct 07, 2005
1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
K052621 · MOS
Usa Instruments, Inc.
Radiology · 14d
Cleared Oct 07, 2005
GEMINI RAPTOR
K052640 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 11d
Cleared Oct 05, 2005
ETIAM STAR PACS COMPONENTS
K052358 · LLZ
Etiam, S.A.
Radiology · 37d
Cleared Oct 04, 2005
MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
K052164 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 56d
Cleared Oct 04, 2005
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
K052430 · KPS
Digirad Corp.
Radiology · 28d
Cleared Oct 04, 2005
3T HD BREAST ARRAY
K052585 · MOS
Usa Instruments, Inc.
Radiology · 14d
Cleared Sep 30, 2005
IPLAN RT FIBERTRACKING
K052220 · IYE
Brainlab AG
Radiology · 46d
Cleared Sep 30, 2005
COLOR CORONIS 2MP-21 AND MFCD 2321
K052352 · LLZ
Barcoview
Radiology · 32d
Cleared Sep 30, 2005
E-2320 PA S
K052529 · LLZ
Barcoview
Radiology · 16d
Cleared Sep 29, 2005
SITE-RITE 5 ULTRASOUND SYSTEM
K052517 · ITX
C.R. Bard, Inc.
Radiology · 15d
Cleared Sep 28, 2005
MFCD 1219, MFCD 1219 TS
K052478 · LLZ
Barcoview
Radiology · 19d
Cleared Sep 27, 2005
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
K052172 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 49d
Cleared Sep 27, 2005
THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)
K052422 · EAP
Flow X-Ray Corp.
Radiology · 25d
Cleared Sep 27, 2005
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
K052434 · KPS
GE Medical Systems
Radiology · 21d
Cleared Sep 27, 2005
PORTAL GRAVITY SYSTEM
K052579 · LNH
Portal, Inc.
Radiology · 7d
Cleared Sep 22, 2005
21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)
K052199 · LLZ
Totoku Electric Co., Ltd.
Radiology · 41d
Cleared Sep 22, 2005
SIMTEC IM-MAXX 2 OPTION
K052315 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Sep 22, 2005
ACUSON SEQUOIA ULTRASOUND SYSTEM
K052410 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Sep 22, 2005
SYNGO IMAGING VERSION V20A
K052461 · LLZ
Siemens AG Medical Solutions
Radiology · 14d
Cleared Sep 21, 2005
MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001
K051494 · MQB
Cr Tech, Ltd.
Radiology · 107d
Cleared Sep 21, 2005
NIO 2MP-20 AND E-2620 S
K052276 · LLZ
Barcoview
Radiology · 30d
Cleared Sep 21, 2005
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
K052293 · LNH
Ge Medical Systems, LLC
Radiology · 29d