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
12073–12096 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 07, 1993
EDGE SYSTEM
K932693 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 126d
Cleared Oct 07, 1993
SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER
K932777 · ITX
Peripheral Systems Group
Radiology · 121d
Cleared Oct 07, 1993
HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE
K933073 · IZI
Heartware Intl. Corp.
Radiology · 106d
Cleared Oct 07, 1993
LUMISCAN 50
K933129 · LMA
Lumisys, Inc.
Radiology · 101d
Cleared Oct 07, 1993
SPECTRUM DG-P7000 PEDIATRIC CRADLE
K933134 · KXH
Spectrum X-Ray Corp.
Radiology · 101d
Cleared Oct 07, 1993
ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN
K933161 · EAM
Dupont Medical Products
Radiology · 100d
Cleared Oct 07, 1993
MRX-750
K933162 · ITY
Mrx Corp.
Radiology · 100d
Cleared Oct 07, 1993
3-WAY HEAD IMMOBILIZER
K933613 · IYE
Bionix Development Corp.
Radiology · 80d
Cleared Oct 07, 1993
PITUITARY BOARD
K933614 · IYE
Bionix Development Corp.
Radiology · 80d
Cleared Oct 07, 1993
PHILIPS XRG 90 X-RAY GENERATOR SYSTEM
K933650 · IZO
Philips Medical Systems North...
Radiology · 72d
Cleared Oct 07, 1993
MAVIG ANGIO SHIELD MODELS 6290 & 6272
K934206 · KPY
F. Walter Hanel GmbH
Radiology · 38d
Cleared Oct 05, 1993
DIGITAL IMAGE COMMUNICATIONS SYSTEM
K933103 · LMD
Analogic Corp.
Radiology · 103d
Cleared Oct 05, 1993
ORTHOTRAC COAXIAL LASER
K933431 · OXO
Trac Medical, Inc.
Radiology · 83d
Cleared Sep 30, 1993
SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A
K925434 · ITX
Kretz Technik
Radiology · 337d
Cleared Sep 29, 1993
VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS
K925094 · EHD
Gendex Corp.
Radiology · 357d
Cleared Sep 29, 1993
MRINNERVU DISPOSABLE ENDORECTAL COLON COIL,#PCC-15
K930544 · LNH
Medrad, Inc.
Radiology · 239d
Cleared Sep 29, 1993
VISIONTOOL
K933209 · LLZ
Evergreen Technologies, Inc.
Radiology · 90d
Cleared Sep 28, 1993
CFM-800 COLOR FLOW MAPPING SYSTEM
K924079 · IYO
Diasonics, Inc.
Radiology · 411d
Cleared Sep 28, 1993
SURFAS
K925081 · ITX
D.O. Weaver and Co.
Radiology · 356d
Cleared Sep 28, 1993
ULTRA COMPACT VIDEO IMAGER
K930755 · LMC
International Imaging Electronics
Radiology · 228d
Cleared Sep 28, 1993
CARDIOMETRICS FLOWIRE & FLOMAP
K932536 · ITX
Cardio Metrics, Inc.
Radiology · 125d
Cleared Sep 28, 1993
KODAK XML 300 DARKROOM FILM FEEDER
K933001 · IXW
Eastman Kodak Company
Radiology · 99d
Cleared Sep 28, 1993
HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW
K933058 · IZI
Heartware Intl. Corp.
Radiology · 98d
Cleared Sep 24, 1993
VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800
K926108 · ITX
Vingmed Sound, Inc.
Radiology · 295d