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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,668 results
11977–12000 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 06, 1994
SHEATHES, STERILE SHEATHES
K925869 · ITX
Mayer Laboratories
Radiology · 413d
Cleared Jan 05, 1994
RADIATION TREATMENT FOR CANCER PATIENTS
K930182 · IYE
Northwest Medical Physics Center
Radiology · 356d
Cleared Jan 05, 1994
IMPAX 5000
K934386 · LMD
Heraeus Kulzer, Inc.
Radiology · 119d
Cleared Jan 05, 1994
EXTRA LARGE QUAD FLEX SPINE COIL
K934719 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 96d
Cleared Dec 29, 1993
MAXIVIEW DIAGNOSTIC WORKSTATION
K930500 · LMD
Dimensional Medicine, Inc.
Radiology · 331d
Cleared Dec 27, 1993
FAST SPIN ECHO
K934212 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 119d
Cleared Dec 23, 1993
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K934499 · LNH
GE Medical Systems
Radiology · 100d
Cleared Dec 15, 1993
POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)
K933664 · IZI
Siemens Gammasonics, Inc.
Radiology · 140d
Cleared Dec 15, 1993
PANORAMIC X-RAY UNITS, MODIFICATION
K934063 · EHD
Planmeca Oy
Radiology · 106d
Cleared Dec 15, 1993
MPQ-42
K934944 · IZP
Elema-Schonander, Inc.
Radiology · 58d
Cleared Dec 15, 1993
NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY...
K935397 · IXA
Victoreen, Inc.
Radiology · 36d
Cleared Dec 14, 1993
KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR
K931315 · IXW
Konica Medical Corp.
Radiology · 274d
Cleared Dec 14, 1993
KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR
K931316 · IXW
Konica Medical Corp.
Radiology · 274d
Cleared Dec 14, 1993
KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR
K931317 · IXW
Konica Medical Corp.
Radiology · 274d
Cleared Dec 14, 1993
IMAGEACCESS SYSTEM
K931454 · LNH
Image Premastering Services, Inc.
Radiology · 266d
Cleared Dec 14, 1993
MERIT
K931656 · LNH
Picker International
Radiology · 253d
Cleared Dec 14, 1993
PHASED ARRAY/BILATERAL QUADRATURE CONTOUR COIL
K932091 · LNH
Magnetic Research, Inc.
Radiology · 228d
Cleared Dec 14, 1993
MERIT
K933356 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 158d
Cleared Dec 14, 1993
KONICA LD-4500 LASER DIGITIZER
K933830 · LMA
Konica Medical Corp.
Radiology · 131d
Cleared Dec 14, 1993
IMPAX 3000
K934832 · JAK
Heraeus Kulzer, Inc.
Radiology · 67d
Cleared Dec 13, 1993
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
K923697 · KXK
Radionics, Inc.
Radiology · 507d
Cleared Dec 13, 1993
PRACTICE PARTNER
K926315 · LMD
Rs Imaging
Radiology · 363d
Cleared Dec 13, 1993
MODEL 500-6 RADIATION THERAPY IONIZATION CHAMBER
K932342 · LNN
Victoreen, Inc.
Radiology · 213d
Cleared Dec 13, 1993
HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY
K932410 · IZI
Heartware Intl. Corp.
Radiology · 209d