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
8569–8592 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 24, 2003
APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4
K033001 · KPS
Transphoton Corporation
Radiology · 90d
Cleared Dec 24, 2003
VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS
K033371 · JAQ
Varian Medical Systems
Radiology · 64d
Cleared Dec 24, 2003
PORTASCAN BLADDER SCANNER, MODEL PA00146
K033906 · IYO
Mediwatch Plc
Radiology · 7d
Cleared Dec 23, 2003
ERGO SRS
K031281 · MUJ
3D Line USA, Inc.
Radiology · 245d
Cleared Dec 23, 2003
TRILOGY RADIOTHERAPY DELIVERY SYSTEM
K033343 · IYE
Varian Medical Systems, Inc.
Radiology · 67d
Cleared Dec 23, 2003
MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1
K033712 · LLZ
Sectra-Imtec AB
Radiology · 27d
Cleared Dec 23, 2003
SYNGO PERFUSION-CT
K033832 · JAK
Siemens AG Medical Solutions
Radiology · 13d
Cleared Dec 19, 2003
EXACTRAC GATING
K033287 · IYE
Brainlab AG
Radiology · 66d
Cleared Dec 19, 2003
ALLEGRO IMAGING SYSTEM
K033782 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 15d
Cleared Dec 19, 2003
SIENET COSMOS
K033831 · LLZ
Siemens AG Medical Solutions
Radiology · 9d
Cleared Dec 19, 2003
GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS
K033867 · LNH
General Electric Co.
Radiology · 7d
Cleared Dec 17, 2003
MODIFICATION TO: NUCAMMA RX
K032779 · KPS
Is2 Research, Inc.
Radiology · 100d
Cleared Dec 17, 2003
GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL
K033235 · MOS
Usa Instruments, Inc.
Radiology · 72d
Cleared Dec 17, 2003
MEDICAL IMAGE DIGITIZER, MODEL 2908
K033637 · LMA
Array Corp.
Radiology · 28d
Cleared Dec 17, 2003
PELVIC ARRAY COIL
K033753 · MOS
Usa Instruments, Inc.
Radiology · 16d
Cleared Dec 15, 2003
ACCUSOFT
K032171 · IYE
Direx Systems Corp.
Radiology · 152d
Cleared Dec 15, 2003
TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L
K033604 · IYO
Pie Medical
Radiology · 28d
Cleared Dec 15, 2003
PACS SOFTWARE SOLUTION 2003
K033624 · LLZ
Canon USA, Inc.
Radiology · 27d
Cleared Dec 12, 2003
TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
K031812 · DXC
Vascular Control Systems, Inc.
Radiology · 183d
Cleared Dec 12, 2003
CLARITY PET
K032866 · KPS
Shared P.E.T. Imaging, LLC
Radiology · 88d
Cleared Dec 12, 2003
VANTAGE PRO ATTENUATION CORRECTION DEVICE
K033735 · KPS
Adac Laboratories
Radiology · 14d
Cleared Dec 09, 2003
OB1 OBSTETRICAL DOPPLER
K033156 · KNG
D. E. Hokanson, Inc.
Radiology · 70d
Cleared Dec 09, 2003
LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400
K033184 · IZI
Shimadzu Corp.
Radiology · 69d
Cleared Dec 09, 2003
ALLURA XPER FD20
K033737 · OWB
Philips Medical Systems North...
Radiology · 11d