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
6577–6600 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 11, 2009
DIGITAL LIGHTBOX
K093117 · LLZ
Brainlab AG
Radiology · 70d
Cleared Dec 11, 2009
DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4
K091364 · LLZ
Oehm Und Rehbein GmbH
Radiology · 217d
Cleared Dec 11, 2009
GAMMALOC SYSTEM, MODEL 03-00001
K082588 · IYX
Dilon Technologies, LLC
Radiology · 459d
Cleared Dec 10, 2009
SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
K093714 · ITX
Medison Co., Ltd.
Radiology · 8d
Cleared Dec 10, 2009
DISCOVERY MODEL NM/CT 670
K093514 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 27d
Cleared Dec 10, 2009
EAGLE EYE PLATINUM DIGITAL IVUS CATHETER
K092596 · OBJ
Volcano Corporation
Radiology · 108d
Cleared Dec 10, 2009
PRESIDIO PACS
K092125 · LLZ
Reaonix Security, LLC
Radiology · 148d
Cleared Dec 07, 2009
ALATUS VAGINAL BALLOON PACKING SYSTEM
K092534 · JAQ
Radiadyne
Radiology · 110d
Cleared Dec 04, 2009
VIAMO SSA-640A VERSION 1.2
K093171 · IYN
Toshiba America Medical Systems, In.C
Radiology · 57d
Cleared Dec 02, 2009
SYNERGY
K093313 · NFJ
Topcon Medical Systems, Inc.
Radiology · 41d
Cleared Dec 02, 2009
MEDSYNAPSE PACS SOFTWARE
K093247 · LLZ
Medsynaptic Private, Ltd.
Radiology · 48d
Cleared Dec 02, 2009
INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA...
K092639 · LLZ
GE Medical Systems SCS
Radiology · 97d
Cleared Dec 02, 2009
IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4...
K091934 · JAK
Veran Medical Technologies, Inc.
Radiology · 155d
Cleared Dec 02, 2009
MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR
K090526 · MUH
E-Woo Technology
Radiology · 279d
Cleared Dec 01, 2009
ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM
K093531 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 15d
Cleared Nov 30, 2009
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
K093453 · EAP
Schick Technologies, Inc.
Radiology · 25d
Cleared Nov 30, 2009
IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200
K093146 · JAK
Veran Medical Technologies, Inc.
Radiology · 56d
Cleared Nov 30, 2009
TRILOGY MX
K092871 · IYE
Varian Medical Systems, Inc.
Radiology · 73d
Cleared Nov 30, 2009
CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF
K092439 · OWB
Virtual Imaging, Inc.
Radiology · 112d
Cleared Nov 25, 2009
3.0T 16 CHANNEL HEAD NECK SPINE COIL
K093348 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 29d
Cleared Nov 25, 2009
MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01
K092230 · LNH
Time Medical Limited
Radiology · 125d
Cleared Nov 24, 2009
INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
K090584 · JAD
Carl Zeiss Surgical GmbH
Radiology · 266d
Cleared Nov 20, 2009
ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM
K093488 · IYO
Aloka Co., Ltd.
Radiology · 10d
Cleared Nov 20, 2009
SONIX ULTRASOUND SCANNER
K093462 · ITX
Ultrasonix Medical Corporation
Radiology · 14d