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
5569–5592 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 20, 2012
SYNGO, CT CARDIAC FUNCTION
K123585 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Dec 20, 2012
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
K123530 · LLZ
Hologic, Inc.
Radiology · 34d
Cleared Dec 20, 2012
SCENIUM
K123528 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Dec 20, 2012
AEROPILOT
K123499 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 37d
Cleared Dec 20, 2012
TRUEBEAM
K123291 · IYE
Varian Medical Systems, Inc.
Radiology · 59d
Cleared Dec 18, 2012
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
K123564 · IYN
Ge Healthcare
Radiology · 28d
Cleared Dec 18, 2012
HERMES MEDICAL IMAGING SUITE V5.2
K121278 · KPS
Hermes Medical Solutions AB
Radiology · 232d
Cleared Dec 14, 2012
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
K122840 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 88d
Cleared Dec 14, 2012
PERCUNAV
K121498 · JAK
Philips Health Care
Radiology · 207d
Cleared Dec 13, 2012
PRESTO 1000 SYSTEM
K123565 · IYN
Physiosonics, Inc.
Radiology · 23d
Cleared Dec 13, 2012
DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM
K123503 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 30d
Cleared Dec 13, 2012
VEX-S 100W INTRAORAL X-RAY SYSTEM
K123493 · EHD
VATECH Co., Ltd.
Radiology · 34d
Cleared Dec 13, 2012
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
K123492 · MOS
Philips Medical Systems
Radiology · 30d
Cleared Dec 13, 2012
VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US
K122613 · LNH
Toshiba America Medical Systems, In.C
Radiology · 108d
Cleared Dec 12, 2012
MOSAIQ ONCOLOGY INFORMATION SYSTEM
K123230 · IYE
Impac Medical Systems, Inc.
Radiology · 58d
Cleared Dec 11, 2012
MAVRIC SL
K113394 · LNH
Ge Medical Systems, LLC
Radiology · 391d
Cleared Dec 10, 2012
OP300
K122018 · OAS
Palodex Group OY
Radiology · 153d
Cleared Dec 10, 2012
CARDNAV
K120282 · OWB
Paieon, Inc.
Radiology · 314d
Cleared Dec 07, 2012
VITESSE 3.0
K123152 · MUJ
Varian Medical Systems, Oncology Systems
Radiology · 59d
Cleared Dec 07, 2012
DDRVERSA MOTION
K123005 · MQB
Swissray Medical AG
Radiology · 71d
Cleared Dec 07, 2012
DENTAL X-RAY Z70 (W)
K122582 · EHD
Denterprise International, Inc.
Radiology · 106d
Cleared Dec 06, 2012
MRJ 3300
K122034 · LNH
Paramed S.R.L.
Radiology · 148d
Cleared Dec 05, 2012
ACUSON
K123622 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 12d
Cleared Dec 05, 2012
LESSRAY
K123226 · OWB
Saferay Spine, LLC
Radiology · 51d