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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
6793–6816 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 06, 2009
CARESTREAM DRX-1 SYSTEM
K090318 · MQB
Carestream Health, Inc.
Radiology · 56d
Cleared Apr 03, 2009
INFANT CARDIAC ARRAY
K083539 · MOS
Advanced Imaging Research, Inc.
Radiology · 126d
Cleared Apr 03, 2009
YIELD MINI DOPPLER SYSTEM
K090743 · IYN
Broncus Technologies, Inc.
Radiology · 14d
Cleared Apr 03, 2009
PINNACLE3 SMARTARC
K090808 · MUJ
Philips Medical Systems, Inc.
Radiology · 9d
Cleared Apr 01, 2009
SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY
K083524 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 124d
Cleared Mar 31, 2009
ACUSON P50 ULTRASOUND SYSTEM
K083114 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 161d
Cleared Mar 31, 2009
CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING
K083446 · LLZ
Ziosoft, Inc.
Radiology · 130d
Cleared Mar 31, 2009
ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024
K090223 · LLZ
Icad, Inc.
Radiology · 60d
Cleared Mar 31, 2009
AUTOSPECT
K090403 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 42d
Cleared Mar 31, 2009
LIFEDOP MODEL, L350R
K090499 · MAA
Summit Doppler Systems, Inc.
Radiology · 34d
Cleared Mar 31, 2009
NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER
K090553 · KPS
Naviscan, Inc.
Radiology · 29d
Cleared Mar 30, 2009
SENTINEL, MODEL SP-001
K082582 · IYE
C-Rad Positioning AB
Radiology · 203d
Cleared Mar 27, 2009
VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE
K090649 · LLZ
Virtual Radiologic Corporation
Radiology · 16d
Cleared Mar 25, 2009
I_OPEN 0.4T
K090433 · LNH
Beijing Wandong Medical Equipment...
Radiology · 34d
Cleared Mar 24, 2009
CPI RAD VISION, MODEL VZW2944XX-YY
K083224 · MQB
Communications & Power Industries...
Radiology · 141d
Cleared Mar 24, 2009
DIGITAL RADIOGRAPHY CXDI-40G COMPACT
K090623 · MQB
Canon USA, Inc.
Radiology · 15d
Cleared Mar 24, 2009
WIRELESS PORTABLE DETECTOR FD-W17
K090625 · MQB
Philips Medical Systems North America...
Radiology · 15d
Cleared Mar 23, 2009
BRIT PACS SYSTEMS
K081168 · LLZ
Brit Systems, Inc.
Radiology · 333d
Cleared Mar 23, 2009
BIOGRAPH 16 TRUE POINT SYSTEMS
K083852 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Mar 23, 2009
CIRRUS OPEN
K090080 · LNH
Mri-Tech Sp. Zo.O.
Radiology · 70d
Cleared Mar 19, 2009
DEMASQ IMAGING SPFTWARE DEVICE
K090481 · LLZ
Demasq Limited
Radiology · 23d
Cleared Mar 17, 2009
EASY MOVING PLUS, SM-XXHF-YY
K090322 · IZL
Sedecal., Sa.
Radiology · 36d
Cleared Mar 16, 2009
SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64
K090267 · MOS
Midwest Rf, LLC
Radiology · 41d
Cleared Mar 16, 2009
UROCARE
K090552 · LLZ
Neusoft Medical Systems Co., Ltd.
Radiology · 14d