FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
6505–6528 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 23, 2010
SYNGO.PET&CT ONCOLOGY
K093621 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 92d
Cleared Feb 23, 2010
CORVUS RADIATION THERAPY PLANNING SYSTEM
K100092 · MUJ
Best Nomos
Radiology · 41d
Cleared Feb 19, 2010
SONALIS
K100204 · ITX
Smith Associates
Radiology · 25d
Cleared Feb 04, 2010
EXAPACS
K093444 · LLZ
Medincom Technology Corp
Radiology · 91d
Cleared Feb 04, 2010
CANON, MODEL URS-50RF
K093688 · OWB
Virtual Imaging, Inc.
Radiology · 66d
Cleared Feb 03, 2010
R650 QDASM COLLIMATOR
K093572 · IZW
Omega Medical Imaging, Inc.
Radiology · 77d
Cleared Feb 01, 2010
1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL
K093284 · MOS
Invivo Corporation
Radiology · 104d
Cleared Feb 01, 2010
IU22 ULTRASOUND SYSTEM AND TRANSDUCERS
K093563 · IYN
Philips Ultrasound, Inc.
Radiology · 75d
Cleared Jan 28, 2010
SHOULDER SPEEDER COIL
K093667 · MOS
Quality Electrodynamics
Radiology · 62d
Cleared Jan 28, 2010
MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
K100067 · ITX
Toshiba America Medical Systems, In.C
Radiology · 17d
Cleared Jan 27, 2010
IG 4 IMAGE GUIDED SYSTEM
K093995 · JAK
Veran Medical Technologies, Inc.
Radiology · 30d
Cleared Jan 26, 2010
RESPISENS
K092845 · IYE
Nomics
Radiology · 133d
Cleared Jan 21, 2010
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
K093427 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 79d
Cleared Jan 19, 2010
NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/...
K093693 · MOS
Noras Mri Products GmbH
Radiology · 50d
Cleared Jan 19, 2010
3DI
K093703 · LLZ
Shina Systems , Ltd.
Radiology · 49d
Cleared Jan 19, 2010
ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
K093713 · ITX
Civco Medical Instruments
Radiology · 49d
Cleared Jan 19, 2010
ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
K093849 · IYN
Medison Co., Ltd.
Radiology · 34d
Cleared Jan 12, 2010
LUMOS, MODEL R 72B
K093596 · KPW
Lumos, Inc.
Radiology · 53d
Cleared Jan 11, 2010
SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL
K092479 · IYE
Dyn'R
Radiology · 151d
Cleared Jan 11, 2010
EXPLORER 4D TREATMENT PLANNING SYSTEM
K093588 · MUJ
American Radiosurgery, Inc.
Radiology · 53d
Cleared Jan 08, 2010
DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D
K090467 · OAS
VATECH Co., Ltd.
Radiology · 319d
Cleared Jan 08, 2010
PCR ELEVA 1.2
K093355 · LLZ
Philips Medical Systems, Inc.
Radiology · 73d
Cleared Jan 08, 2010
XELERIS 3 PROCESSING AND REVIEW WORKSTATION
K093982 · LLZ
Ge Medical Systems F.I. Haifa
Radiology · 15d
Cleared Jan 07, 2010
VIDAR DENTAL FILM DIGITIZER
K093809 · LMA
Vidar Systems Corp.
Radiology · 29d