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
8569–8592 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 17, 2004
QLAB QUANTIFICATION SOFTWARE
K040227 · LLZ
Philips Ultrasound
Radiology · 15d
Cleared Feb 12, 2004
SIREMOBILE C06
K040066 · OXO
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Feb 10, 2004
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER...
K032067 · JAQ
Proxima Therapeutics, Inc.
Radiology · 222d
Cleared Feb 09, 2004
CSTAT, MODELS 09-0014-01 AND 09-0014-02
K032125 · DXC
Vascular Control Systems, Inc.
Radiology · 214d
Cleared Feb 06, 2004
ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE
K040142 · LLZ
Adac Laboratories
Radiology · 15d
Cleared Feb 04, 2004
SIMULIX EVOLUTION
K033470 · KPQ
Nucletron Corporation
Radiology · 93d
Cleared Feb 02, 2004
CHASE CARDIAC ANALYSIS SYSTEM
K032531 · LLZ
Chase Medical, Inc.
Radiology · 171d
Cleared Feb 02, 2004
PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF
K032628 · IZL
United Radiology Systems, Inc.
Radiology · 160d
Cleared Feb 02, 2004
SYNERGY SPINE ARRAY COIL
K033662 · MOS
Philips Medical Systems, Inc.
Radiology · 73d
Cleared Feb 02, 2004
ORTHOPACS
K033825 · LLZ
Etrauma.Com Corp.
Radiology · 54d
Cleared Feb 02, 2004
CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406
K033828 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 54d
Cleared Feb 02, 2004
MINXRAY, MODEL HF120/60H POWERPLUS
K040046 · IZL
Minxray, Inc.
Radiology · 21d
Cleared Feb 02, 2004
MOBILE COMPACT DIGITAL CARDIAC CAMERA
K040057 · KPS
Is2 Research, Inc.
Radiology · 20d
Cleared Jan 30, 2004
CP SLEEVE AND RIVER SLEEVE
K034062 · KXK
Cp Medical
Radiology · 30d
Cleared Jan 30, 2004
EMORY CARDIAC TOOLBOX VERSION 2.6
K040141 · KPS
Syntermed, Inc.
Radiology · 8d
Cleared Jan 28, 2004
SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS
K040060 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Jan 22, 2004
CA-1500
K040028 · LLZ
R2 Technology, Inc.
Radiology · 14d
Cleared Jan 21, 2004
INTUITION IMAGE
K032511 · LHN
Brainlab AG
Radiology · 160d
Cleared Jan 20, 2004
MRJ
K033507 · LNH
Paramed S.R.L.
Radiology · 76d
Cleared Jan 20, 2004
MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)
K033956 · KPS
Is2 Research, Inc.
Radiology · 29d
Cleared Jan 09, 2004
TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM
K032585 · HDC
Ron-Tech Medical , Ltd.
Radiology · 141d
Cleared Jan 09, 2004
DIAMOND SETUP 2000
K032886 · LHN
K&S Assoc., Inc.
Radiology · 115d
Cleared Jan 09, 2004
ACQSIM-MULTISLICE-CT, MODEL 453567042271
K033357 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 81d
Cleared Jan 09, 2004
FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L
K033377 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 79d