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
9337–9360 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Oct 18, 2001
MR-GUIDE 2000
K013150 · LNH
Ultraguide , Ltd.
Radiology · 28d
Cleared Oct 18, 2001
MOSFET AUTOSENSE, MODEL TN-RD-60
K013279 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 16d
Cleared Oct 17, 2001
SEED SELECTRON MODEL V. 1.0
K010032 · JAQ
Nucletron Corp.
Radiology · 287d
Cleared Oct 16, 2001
HRH-63-8 HEAD ARRAY COIL
K013159 · MOS
Mri Devices Corp.
Radiology · 25d
Cleared Oct 16, 2001
MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE
K013176 · EHD
Afp Imaging Corp.
Radiology · 22d
Cleared Oct 16, 2001
HAC-420 HEAD ARRAY COIL
K013322 · MOS
Mri Devices Corp.
Radiology · 11d
Cleared Oct 12, 2001
LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
K013229 · IXA
Ferrania USA, Inc.
Radiology · 15d
Cleared Oct 05, 2001
DIASUS
K013142 · IYO
Dynamic Imaging , Ltd.
Radiology · 15d
Cleared Oct 05, 2001
CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A
K013214 · JAK
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Oct 01, 2001
SOLID STATE X-RAY IMAGING DEVICES
K003238 · MQB
Cares Built, Inc.
Radiology · 349d
Cleared Oct 01, 2001
EXPRESSSUITE
K011049 · LMA
Vidar Systems Corp.
Radiology · 178d
Cleared Oct 01, 2001
MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1
K012227 · IYE
Oncology Data Systems, Inc.
Radiology · 77d
Cleared Oct 01, 2001
DOSERIGHT
K012238 · JAK
Philips Medical Systems North America...
Radiology · 76d
Cleared Oct 01, 2001
CTS-485 ULTRASOUND IMAGING SYSTEM
K012772 · IYO
Shantou Institute of Ultrasonic...
Radiology · 45d
Cleared Oct 01, 2001
EXHALE PROBE
K013111 · EOQ
Broncus Technologies, Inc.
Radiology · 13d
Cleared Sep 28, 2001
RAPIDIA
K012290 · LLZ
3D Med Co., Ltd.
Radiology · 70d
Cleared Sep 28, 2001
ADC COMPACT PLUS
K013138 · MQB
Agfa-Gevaert AG
Radiology · 9d