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
9745–9768 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Apr 27, 2000
STEROTACTIC LOCALIZATION DEVICE (SLD)
K000832 · LNH
Philips Medical Systems North...
Radiology · 44d
Cleared Apr 27, 2000
THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE
K001006 · IWB
Mds Nordion
Radiology · 29d
Cleared Apr 24, 2000
VISION R/F TILTING TABLE
K000412 · IXR
Villa Sistemi Medicali S.P.A.
Radiology · 76d
Cleared Apr 24, 2000
REMOTE FETAL MEDICINE ULTRASOUND SYSTEM
K000443 · LLZ
R4 Telemedicine, Inc.
Radiology · 74d
Cleared Apr 24, 2000
MEDVIZER PACS, MODEL RELEASE 2000
K000557 · LLZ
Vitel Net
Radiology · 66d
Cleared Apr 24, 2000
GE LOGIQ 700
K001016 · ITX
GE Medical Systems
Radiology · 26d
Cleared Apr 20, 2000
PACSSTATION
K000448 · LLZ
Fernandez Industries, Inc.
Radiology · 70d