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
5785–5808 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 17, 2012
MRI SYTEMS
K113281 · LNH
Shenzhen Anke High-Tech Co., Ltd.
Radiology · 192d
Cleared May 15, 2012
QLAB WITH FHN AND VPQ PLUG-IN
K121223 · LLZ
Philips Ultrasound, Inc.
Radiology · 22d
Cleared May 10, 2012
EZSENSOR P DIGITAL INTRAORAL SENSOR
K121132 · MQB
Humanray Co,Ltd
Radiology · 27d
Cleared May 08, 2012
SOMATOM DEFINITION FLASH
K121072 · JAK
Siemens Medical Systems, Inc.
Radiology · 29d
Cleared May 08, 2012
SYNAPSE 3D BRAIN PERFUSION
K120637 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 68d
Cleared May 07, 2012
APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM
K120106 · MUH
Apixia, Inc.
Radiology · 115d
Cleared May 07, 2012
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW,...
K113732 · JAK
Brainlab AG
Radiology · 140d
Cleared May 04, 2012
VIVIX-S
K120020 · MQB
Vieworks Co., Ltd.
Radiology · 122d
Cleared May 03, 2012
RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE
K120344 · JAQ
Radiadyne, LLC (Specification Developer)
Radiology · 90d
Cleared May 03, 2012
EMBRACE THERMOPLASTIC
K120335 · IYE
Bionix Development Corp.
Radiology · 90d
Cleared May 03, 2012
ATAL-8
K113812 · MQB
Atlaim
Radiology · 132d
Cleared May 03, 2012
GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
K113341 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 171d
Cleared May 02, 2012
ECHOSTAR SPICA 1.5T MR SYSTEM
K113511 · LNH
Alltech Medical Systems America, Inc.
Radiology · 156d
Cleared May 01, 2012
SPEEDUP SOFTWARE OPTION
K120748 · LNH
Esaote, S.P.A.
Radiology · 50d
Cleared May 01, 2012
ECHELON OVAL MRI SYSTEM
K113145 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 189d
Cleared Apr 27, 2012
VOLUSON S6, VOLUSON S8
K120741 · IYN
Ge Healthcare
Radiology · 46d
Cleared Apr 27, 2012
PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM
K120341 · JAQ
Varian Medical Systems, Inc.
Radiology · 84d
Cleared Apr 27, 2012
ACCUDXA2
K113616 · KGI
Lone Oak Medical Technologies, LLC
Radiology · 142d
Cleared Apr 27, 2012
SURGICASE CONNECT
K113599 · LLZ
Materialise NV
Radiology · 144d
Cleared Apr 27, 2012
ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS
K113286 · KGI
Ge Medical Systems Lunar
Radiology · 172d
Cleared Apr 23, 2012
VISIA
K120207 · LLZ
Mevis Medical Solutions AG
Radiology · 90d
Cleared Apr 23, 2012
FLAT PANEL DETECTOR
K111824 · MQB
Canon Inc. -Medical Equipment Group
Radiology · 300d
Cleared Apr 20, 2012
3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W
K113240 · LLZ
Eizo Nanao Corporation
Radiology · 170d
Cleared Apr 19, 2012
OPTIMA NM/CT 640
K121019 · KPS
Ge Healthcare
Radiology · 15d