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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,520 results
13561–13584 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 07, 1988
LUM VASCULAR PROCEDURE SYSTEM #B5200A
K883664 · IYB
General Electric Co.
Radiology · 73d
Cleared Nov 04, 1988
NIOBI-X RADIATION REDUCTION FILTER
K882939 · ITY
American Canadian Products, Inc.
Radiology · 114d
Cleared Nov 04, 1988
HP 77025A/77030A ULTRA. SYSTEM/HP 77020CV UPGRADE
K883481 · IYO
Hewlett-Packard Co.
Radiology · 80d
Cleared Nov 04, 1988
MEDRAD OMNIPLANE 300 SYSTEM
K883834 · KPR
Medrad, Inc.
Radiology · 56d
Cleared Nov 03, 1988
CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALY
K882271 · LLZ
Nuccardiac Software, Inc.
Radiology · 156d
Cleared Oct 31, 1988
SIEMENS PACS/I-A
K880690 · IZI
Siemens Gammasonics, Inc.
Radiology · 252d
Cleared Oct 31, 1988
B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER
K883699 · LNH
Fonar Corp.
Radiology · 62d
Cleared Oct 21, 1988
REPORT AND IMAGE MANAGEMENT SYSTEM
K882754 · LMD
Medical Image Processing Specialists,...
Radiology · 108d
Cleared Oct 21, 1988
HIMOBILIX 2N
K883161 · JAA
Bay X-Ray, Inc.
Radiology · 87d
Cleared Oct 21, 1988
GENESIS 180
K883863 · IXR
Fischer Imaging Corp.
Radiology · 38d
Cleared Oct 21, 1988
MICRO-X 100CP
K884134 · IZO
Fischer Imaging Corp.
Radiology · 21d
Cleared Oct 20, 1988
TANGENT II
K883974 · IZZ
Fischer Imaging Corp.
Radiology · 30d
Cleared Oct 19, 1988
TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM
K881305 · JAK
Toshiba Medical Systems
Radiology · 205d
Cleared Oct 19, 1988
PULSED FLUOROSCOPIC CONTROL MODEL:PF-02
K882358 · IZI
U.S. Imaging, Inc.
Radiology · 134d
Cleared Oct 19, 1988
VISTA MR 2055 HP SYSTEM
K883482 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 64d
Cleared Oct 19, 1988
FAST AND CE-FAST MRI SEQUENCES (FOR NMR 1000)
K883519 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 62d
Cleared Oct 19, 1988
BETA 3000M MOBILE NMR IMAGING SYSTEM
K883648 · LNH
Fonar Corp.
Radiology · 50d
Cleared Oct 19, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H
K883649 · LNH
Instrumentarium Corp.
Radiology · 51d
Cleared Oct 19, 1988
RADKOR SFR-70
K883864 · IYB
Radkor, Inc.
Radiology · 36d
Cleared Oct 19, 1988
RADKOR, RF-159
K883885 · KXJ
Radkor, Inc.
Radiology · 36d
Cleared Oct 13, 1988
BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR
K883092 · IZL
Bennett X-Ray Corp.
Radiology · 83d
Cleared Oct 13, 1988
VFQ HEAD COIL
K883737 · LNH
Resonex, Inc.
Radiology · 42d
Cleared Oct 12, 1988
DIGITRON STENOSIS PROTOCOL
K881481 · LLZ
Siemens Gammasonics, Inc.
Radiology · 187d
Cleared Oct 12, 1988
100-01778-52 ULTRASOUND SYSTEM
K882478 · IYO
Diasonics, Inc.
Radiology · 118d