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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
9289–9312 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 09, 2001
STANDARD IMAGING IVB 1000 WELL CHAMBER
K013548 · KPT
Standard Imaging, Inc.
Radiology · 16d
Cleared Nov 08, 2001
IQUANTIFY, VERSION 1.0
K011196 · LLZ
Insightful Corporation
Radiology · 203d
Cleared Nov 08, 2001
MAROSIS PACS
K012844 · LLZ
Marotech, Inc.
Radiology · 77d
Cleared Nov 08, 2001
LIGHTSPEED 4.0 CT SCANNER SYSTEM
K013561 · JAK
GE Medical Systems
Radiology · 13d
Cleared Nov 07, 2001
GEMINI IMAGING SYSTEM
K013521 · JAK
Adac Laboratories
Radiology · 15d
Cleared Nov 07, 2001
SOMATOM P30 CT SYSTEMS
K013522 · JAK
Siemens Medical Systems, Inc.
Radiology · 15d
Cleared Nov 07, 2001
QWIKSIM VIRTUAL SIMULATION SYSTEM
K013531 · KPQ
Impac Medical Systems, Inc.
Radiology · 15d
Cleared Nov 06, 2001
MODIFICATION TO SKYLIGHT IMAGING SYSTEM
K013496 · KPS
Adac Laboratories
Radiology · 15d
Cleared Nov 02, 2001
OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM
K012546 · KPR
Sedecal USA, Inc.
Radiology · 87d
Cleared Nov 02, 2001
DEEP GRAY
K012563 · LLZ
Cortechs Labs, Inc.
Radiology · 85d
Cleared Nov 02, 2001
ICONNECTION 3D
K012779 · LLZ
Hinnovation, Inc.
Radiology · 74d
Cleared Nov 02, 2001
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
K013481 · KPR
GE Medical Systems
Radiology · 14d
Cleared Oct 31, 2001
OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS
K012495 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Oct 31, 2001
MODIFICATION TO: ECAT LSO PET/CT SCANNER
K013504 · KPS
Cti Pet Systems, Inc.
Radiology · 9d
Cleared Oct 30, 2001
ULTRASOUND TRANSDUCER COVER
K011265 · ITX
Advance Medical Designs, Inc.
Radiology · 188d
Cleared Oct 30, 2001
LIFEJET VIDEO LINK
K013395 · LMA
Ferrania S.P.A.
Radiology · 15d
Cleared Oct 30, 2001
CARDIQ FUNCTION
K013422 · JAK
GE Medical Systems
Radiology · 15d
Cleared Oct 26, 2001
ADVANCED LUNG ANALYSIS-1
K013381 · JAK
General Electric Co.
Radiology · 14d
Cleared Oct 24, 2001
CAAS II QVA
K012475 · LLZ
Pie Medical Imaging BV
Radiology · 83d
Cleared Oct 24, 2001
MACHNET CAROTIDS COIL ARRAY ASSEMBLY
K012491 · MOS
Machnet BV
Radiology · 82d
Cleared Oct 24, 2001
MODIFIED 650 MAMMOGRAPHY SYSTEM
K013290 · IZH
Lorad, A Hologic Co.
Radiology · 22d
Cleared Oct 18, 2001
ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS
K002132 · MUJ
Intelligent Instruments Pvt. , Ltd.
Radiology · 461d
Cleared Oct 18, 2001
SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
K012424 · JAA
Shimadzu Corp.
Radiology · 80d
Cleared Oct 18, 2001
WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL
K012522 · ITX
National Therapy Products, Inc.
Radiology · 73d