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
9001–9024 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 20, 2002
6 CHANNEL BODY COIL
K023571 · MOS
Siemens Medical Systems, Inc.
Radiology · 27d
Cleared Nov 20, 2002
SONOLINE ANTARES ULTRASOUND SYSTEM
K023720 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Nov 18, 2002
GORE 3.0T TORSO ARRAY
K023679 · MOS
W.L. Gore & Associates, Inc.
Radiology · 17d
Cleared Nov 14, 2002
DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
K023434 · LHQ
Dorex, Inc.
Radiology · 30d
Cleared Nov 13, 2002
UNIVERSAL SYSTEM, MODEL QV-800
K023008 · KPR
Quantum Medical Imaging, LLC
Radiology · 65d
Cleared Nov 12, 2002
KLARITY
K022708 · IYE
Larson Products, Inc.
Radiology · 90d
Cleared Nov 08, 2002
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
K023398 · KGI
Hologic, Inc.
Radiology · 30d
Cleared Nov 08, 2002
ECAT LSO PET/CT 16
K023518 · KPS
Cti Pet Systems, Inc.
Radiology · 18d
Cleared Nov 08, 2002
MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL
K023596 · MOS
Medrad, Inc.
Radiology · 11d
Cleared Nov 07, 2002
CENTRICITY PACS PLUS
K023557 · LLZ
GE Medical Systems
Radiology · 15d
Cleared Nov 05, 2002
SIEMENS VIRTUAL SIMULATION (VSIM)
K022036 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Nov 05, 2002
EXTRA LARGE BODY COIL
K023442 · MOS
GE Medical Systems
Radiology · 21d
Cleared Nov 05, 2002
EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2
K023511 · LNH
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Nov 05, 2002
DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
K023586 · MQB
Canon USA, Inc.
Radiology · 11d
Cleared Nov 04, 2002
LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
K022007 · MOS
Usa Instruments, Inc.
Radiology · 138d
Cleared Nov 01, 2002
ULTRASOUND SCANNER, TYPE 1101
K023457 · IYO
B & K Medical A/S
Radiology · 17d
Cleared Oct 30, 2002
PHILIPS DIGITAL IMAGING OPTION RELEASE 1
K023440 · LLZ
Philips Medical Systems
Radiology · 15d
Cleared Oct 30, 2002
PHILIPS MULTIDIAGNOST ELEVA
K023441 · IZI
Philips Medical Systems
Radiology · 15d
Cleared Oct 25, 2002
REAL TIME HDR (220V), MODEL 132.001
K022739 · JAQ
Nucletron Corporation
Radiology · 67d
Cleared Oct 25, 2002
PHILIPS HARMONY RELEASE 1
K022788 · LLZ
Philips Medical Systems North America...
Radiology · 64d
Cleared Oct 25, 2002
VIZDEXTER VERSION 2.0
K022938 · LLZ
Volume Interactions Pte, Ltd.
Radiology · 51d
Cleared Oct 25, 2002
VARISOURCE BREAST TEMPLATE SYSTEM
K023220 · JAQ
Varian Medical Systems
Radiology · 28d
Cleared Oct 24, 2002
SPOT PRO (220V), MODEL 131.099
K022741 · MUJ
Nucletron Corporation
Radiology · 66d
Cleared Oct 24, 2002
E.CAM COMPUTER / E.SOFT WORKSTATION
K023190 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 29d