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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,488 results
10825–10848 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 01, 1996
INTRA-ORAL THERMOPLASTIC SHIELD
K962622 · KPY
Medtec, Inc.
Radiology · 88d
Cleared Oct 01, 1996
BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000
K963585 · IYO
Diagnostic Ultrasound Corp.
Radiology · 22d
Cleared Sep 27, 1996
DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM
K962613 · JAD
Gulmay Medical , Ltd.
Radiology · 86d
Cleared Sep 27, 1996
PATRIOT
K963037 · LLZ
Infimed, Inc.
Radiology · 53d
Cleared Sep 25, 1996
IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS
K962927 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Sep 23, 1996
DIGIPAN
K961826 · EHD
Trophy Radiologie
Radiology · 133d
Cleared Sep 20, 1996
STEP OPTION TO PRISM 2000
K960865 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 200d
Cleared Sep 20, 1996
FLUOROPLUS CARDIAC TV
K961140 · JAA
Cmt Medical Technologies, Ltd.
Radiology · 183d
Cleared Sep 20, 1996
AURORA DIAGNOSTIC WORKSTATION
K962589 · LLZ
Aurora Technology, Inc.
Radiology · 80d
Cleared Sep 20, 1996
ESTEEM 1.5T MRI SYSTEM
K962677 · LNH
Elscint Mr, Inc.
Radiology · 73d
Cleared Sep 20, 1996
KODAK DIGITAL SCIENCE REMOTE CASSETTE
K962896 · KPR
Eastman Kodak Company
Radiology · 57d
Cleared Sep 16, 1996
OLYMPUS MH-246R BALLOON SHEATH
K961048 · ODG
Olympus America, Inc.
Radiology · 185d
Cleared Sep 16, 1996
ENDOSONICS AUTOMATIC PULL BACK DEVICE
K962293 · ITX
Endosonics Corp.
Radiology · 94d
Cleared Sep 16, 1996
MEDLINE RADIOLOGY-DIAGNOSTIC KITS
K962826 · LRO
Medline Industries, Inc.
Radiology · 59d
Cleared Sep 13, 1996
NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES
K962319 · IZD
Neoprobe Corp.
Radiology · 88d
Cleared Sep 12, 1996
POSITRON COINCIDENCE DETECTION
K960192 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 240d
Cleared Sep 11, 1996
JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100
K963334 · IXX
Jamieson Film Co.
Radiology · 16d
Cleared Sep 09, 1996
CAMVISION 1000
K953974 · JAA
Medivision Medical Imaging, Ltd.
Radiology · 383d
Cleared Sep 09, 1996
AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR)
K961023 · LMD
Accuimage, Inc.
Radiology · 179d
Cleared Sep 09, 1996
REAL-TIME VIDEO CONTRAST ENHANCER
K962260 · LLZ
Digivision, Inc.
Radiology · 89d
Cleared Sep 09, 1996
BREAST TREATMENT AID M200
K962487 · IYE
S. and H. Engineering, Inc.
Radiology · 75d
Cleared Sep 05, 1996
SKIN DOSE MONITOR
K961105 · OWB
Mcmahon Medical
Radiology · 169d
Cleared Sep 05, 1996
ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)
K961525 · MOS
Mri Devices Corp.
Radiology · 136d
Cleared Sep 05, 1996
MINI FLEX COIL
K961628 · MOS
W.L. Gore & Associates, Inc.
Radiology · 132d