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
9769–9792 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 26, 2000
LIBERTY 9000 BREAST COIL
K000993 · MOS
Usa Instruments, Inc.
Radiology · 59d
Cleared May 26, 2000
OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K001203 · ITX
The Olympus Optical Co.
Radiology · 43d
Cleared May 26, 2000
MODIFICATION TO ACCUDEXA BONE DENSITOMETER
K001429 · KGI
Schick Technologies, Inc.
Radiology · 21d
Cleared May 26, 2000
IIVS INTEGRATED IMAGE VIEWING STATION
K994329 · LMD
Terarecon,Inc.
Radiology · 156d
Cleared May 24, 2000
PROTON VISION
K000922 · MUJ
Varian Assoc., Inc.
Radiology · 63d
Cleared May 16, 2000
PROVIEW MEDICAL IMAGE DISPLAY MODULE
K000770 · LLZ
Cerner Corp.
Radiology · 68d
Cleared May 16, 2000
ALL-PRO 2010
K001321 · IXW
All-Pro Imaging Corp.
Radiology · 20d
Cleared May 16, 2000
APOLLO MULTI-RACIAL REFERENCE POPULATION
K993337 · KGI
Norland Medical Systems, Inc.
Radiology · 224d
Cleared May 12, 2000
METRISCAN BONE DENSITY SYSTEM
K000162 · KGI
Alara, Inc.
Radiology · 114d
Cleared May 12, 2000
MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM
K000630 · LLZ
Hopkins Imaging Systems, Inc.
Radiology · 78d
Cleared May 12, 2000
PHILIPS CT SECURA MV
K000819 · JAK
Philips Medical Systems North...
Radiology · 60d
Cleared May 12, 2000
DELTA 16 TACT
K001171 · IZH
Instrumentarium Imaging, Inc.
Radiology · 31d
Cleared May 12, 2000
GE SYSTEM FIVE
K001267 · IYN
Ge Medical Systems, Inc.
Radiology · 22d
Cleared May 12, 2000
BALLOON FOR ULTRASONIC ENDOSCOPES
K992178 · ITX
N.M. Beale Co., Inc.
Radiology · 319d
Cleared May 04, 2000
MULTI-PULSE 2000
K001248 · EHD
Imaging Sciences Intl., Inc.
Radiology · 16d
Cleared May 03, 2000
MOTORIZED MICRO MULTILEAF COLLIMATOR
K000349 · IXI
Stryker Leibinger
Radiology · 90d
Cleared May 03, 2000
FOTOMASTER
K000380 · LLZ
Hamilton Thorne Research
Radiology · 86d
Cleared May 03, 2000
EINSTEIN PROCESSING AND REVIEW WORKSTATION
K000395 · LLZ
Ge Medical Systems F.I. Haifa
Radiology · 86d
Cleared May 03, 2000
AU5, AU6
K000681 · IYO
Biosound Esaote, Inc.
Radiology · 65d
Cleared May 03, 2000
DIMAX 2
K000771 · EHD
Planmeca Oy
Radiology · 55d
Cleared May 03, 2000
IDS5 IMAGE DISPLAY SYSTEM
K001140 · LLZ
Sectra AB
Radiology · 23d
Cleared May 02, 2000
SONOS AIRES 600 (SA-600)
K000320 · IYO
Kpi Ultrasound, LLC
Radiology · 90d
Cleared May 02, 2000
HELIODENT VARIO
K000672 · EHD
Sirona Dental Systems GmbH
Radiology · 64d
Cleared Apr 28, 2000
DIXI 2
K000428 · EHD
Planmeca Oy
Radiology · 79d