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
9361–9384 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 27, 2001
NUMARIS 4VA15A
K012202 · LNH
Siemens Medical Corp.
Radiology · 76d
Cleared Sep 26, 2001
SONOREAL 3D
K012084 · IYO
Bio Medi Com
Radiology · 85d
Cleared Sep 25, 2001
ACCUIMAGE SMARTGATE UPGRADE
K012106 · JAK
Accuimage Diagnostics Corp.
Radiology · 81d
Cleared Sep 25, 2001
MODIFICATION TO: QWH-420 WRIST ARRAY COIL
K013099 · MOS
Mri Devices Corp.
Radiology · 8d
Cleared Sep 24, 2001
GE SIGNA ASSET IMAGING OPTION
K012970 · LNH
GE Medical Systems
Radiology · 20d
Cleared Sep 21, 2001
INTRA OPERATIVE RADIATION THERAPY
K004023 · IYE
Arplay Medical S.A.
Radiology · 268d
Cleared Sep 21, 2001
AETMED IMAGE PROCESSING SOFTWARE
K012093 · LLZ
Aetmed, S.P.A.
Radiology · 78d
Cleared Sep 20, 2001
MODIFICATION TO LR 5200 FILM RECORDER
K012010 · LMC
Agfa Corp.
Radiology · 85d
Cleared Sep 19, 2001
AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K012154 · LNH
Aurora Imaging Technology, Inc.
Radiology · 70d
Cleared Sep 19, 2001
OLDELFT THORASCAN MODEL NUMBER 180T
K012165 · KPR
Nucletron Corp.
Radiology · 70d
Cleared Sep 18, 2001
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
K012775 · KPS
GE Medical Systems
Radiology · 29d
Cleared Sep 13, 2001
MX8000 IDT CT SYSTEM
K012009 · JAK
Marconi Medical Systems, Inc.
Radiology · 78d
Cleared Sep 13, 2001
AQUARIUSNET SERVER
K012086 · LLZ
Terarecon,Inc.
Radiology · 72d
Cleared Sep 12, 2001
SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM
K012867 · IYN
Medison America, Inc.
Radiology · 16d
Cleared Sep 12, 2001
SA6000II DIAGNOSTIC ULTRASOUND SYSTEM
K012887 · IYO
Medison America, Inc.
Radiology · 15d
Cleared Sep 07, 2001
MINI MULTILEAF COLLIMATOR, MODEL KMI
K011816 · IXI
Mrc Systems GmbH
Radiology · 88d
Cleared Sep 07, 2001
MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
K012836 · JAK
GE Medical Systems
Radiology · 15d
Cleared Sep 06, 2001
GE VISION NUCLEAR MEDICINE WORKSTATION
K012568 · KPS
General Electric Co.
Radiology · 28d
Cleared Sep 05, 2001
OMNIDOS
K011763 · IYE
Scanditronix Medical AB
Radiology · 90d
Cleared Sep 05, 2001
MHS 5000
K011981 · LHQ
Micro Health Systems, Inc.
Radiology · 72d
Cleared Sep 04, 2001
ACCU-SPACE ABSORBABLE SEEDING SPACERS
K010621 · KXK
Cp Medical
Radiology · 187d
Cleared Aug 31, 2001
MBI PD-103 SL
K011427 · KXK
Mills Biopharmaceuticals, Inc.
Radiology · 115d
Cleared Aug 31, 2001
INTERCEPT-URETHRAL MICROCOIL
K011781 · MOS
Surgi-Vision, Inc.
Radiology · 85d
Cleared Aug 31, 2001
EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)
K012663 · IZL
Sedecal USA, Inc.
Radiology · 18d