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
8497–8520 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 23, 2004
DICOM THEATER
K033153 · LLZ
Ferguson Medical
Radiology · 206d
Cleared Apr 23, 2004
CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO
K040468 · LLZ
Cedara Software Corp.
Radiology · 59d
Cleared Apr 23, 2004
PREVIEW TREATMENT PLANNING SOFTWARE
K040852 · LLZ
Medical Media Systems, Inc.
Radiology · 22d
Cleared Apr 23, 2004
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
K040884 · IZH
Hologic, Inc.
Radiology · 18d
Cleared Apr 23, 2004
TEM 3000 HEAD COIL
K040937 · MOS
Mr Instruments, Inc.
Radiology · 11d
Cleared Apr 21, 2004
HITACHI PRESTO
K040902 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 14d
Cleared Apr 20, 2004
MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE
K033006 · LLZ
Barco NV Barcoview
Radiology · 270d
Cleared Apr 20, 2004
STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE
K033123 · HLI
Carl Zeiss Meditec, Inc.
Radiology · 203d
Cleared Apr 20, 2004
ENDOSCOUT
K033485 · LNH
Robin Medical, Inc.
Radiology · 168d
Cleared Apr 19, 2004
MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY
K033005 · LLZ
Barco NV Barcoview
Radiology · 207d
Cleared Apr 19, 2004
MGD 2621P MEDICAL GREYSCALE DISPLAY
K033104 · LLZ
Barco NV Barcoview
Radiology · 203d
Cleared Apr 19, 2004
SENOGRAPHIC STEREO
K040125 · IZH
Ge Medical Systems, Inc.
Radiology · 90d
Cleared Apr 19, 2004
VIATRONIX V3D COLON, REVISION 1.3
K040126 · LLZ
Viatronix, Inc.
Radiology · 90d
Cleared Apr 19, 2004
ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE
K040876 · LLZ
Vital Images, Inc.
Radiology · 14d
Cleared Apr 16, 2004
MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY
K033004 · LLZ
Barco NV Barcoview
Radiology · 204d
Cleared Apr 16, 2004
MGD 2621L MEDICAL GREYSCALE DISPLAY
K033103 · LLZ
Barco NV Barcoview
Radiology · 200d
Cleared Apr 14, 2004
MAYO CLINIC BC-10 3.0T
K040122 · MOS
Mayo Clinic
Radiology · 85d
Cleared Apr 14, 2004
GE SIGNA 3.0T WITH EXCITE MR SYSTEM
K040444 · LNH
General Electric Co.
Radiology · 85d
Cleared Apr 14, 2004
TERATECH MODEL 10V5 SMART PROBE
K040840 · ITX
Teratech Corp.
Radiology · 13d
Cleared Apr 13, 2004
E-Z SCAN AB5500+
K040668 · IYO
Sonomed, Inc.
Radiology · 29d
Cleared Apr 12, 2004
MFCD 2320
K040158 · LLZ
Barco N.V.
Radiology · 80d
Cleared Apr 09, 2004
PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM
K040773 · IYE
Bionix Development Corp.
Radiology · 14d
Cleared Apr 08, 2004
ISOAID ADVANTAGE PD-103, MODEL IAPD-103A
K033770 · KXK
Isoaid, LLC
Radiology · 127d
Cleared Apr 08, 2004
BRACHYTHERAPY STRAND DEVICE
K040339 · KXK
Bebig Isotopen-Und Medizintechnik GmbH
Radiology · 57d