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
7057–7080 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 23, 2008
INFX-8000C (INFINIX CC-I AND VC-I)
K081621 · JAA
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jun 23, 2008
INFX-8000F (INFINIX CSI AND INFINIX DPI)
K081624 · MQB
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Jun 23, 2008
NOMAD PRO X-RAY SYSTEM
K081664 · EHD
Aribex, Inc.
Radiology · 10d
Cleared Jun 20, 2008
DR VISION NEO, DR VISION DOU
K080614 · KPR
Almana Medical Imaging
Radiology · 107d
Cleared Jun 20, 2008
VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE
K081076 · LLZ
Velocity Medical Solutions, LLC
Radiology · 65d
Cleared Jun 19, 2008
SMITH & NEPHEW CDS SYSTEM
K081491 · JAA
Smith & Nephew, Inc.
Radiology · 22d
Cleared Jun 18, 2008
ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL...
K081198 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 51d
Cleared Jun 18, 2008
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE...
K081322 · MOS
Shanghai Chenguang Medical...
Radiology · 37d
Cleared Jun 18, 2008
PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201
K081340 · MOS
Shanghai Chenguang Medical...
Radiology · 36d
Cleared Jun 17, 2008
MEDRAD INTEGO PET INFUSION SYSTEM
K080297 · FRN
Medrad, Inc.
Radiology · 134d
Cleared Jun 17, 2008
DC NEURO
K081262 · LLZ
Invivo Corporation
Radiology · 43d
Cleared Jun 17, 2008
INFX-8000V, INFINIX-CFI AND INFINIX VFI
K081582 · JAA
Toshiba America Medical Systems, In.C
Radiology · 12d
Cleared Jun 12, 2008
SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2
K081469 · LLZ
Sectra-Imtec AB
Radiology · 16d
Cleared Jun 12, 2008
OPTIMA PET/CT 560
K081496 · KPS
Ge Medical Systems, LLC
Radiology · 14d
Cleared Jun 11, 2008
DESKTOP PRO
K080585 · IYE
Elekta , Ltd.
Radiology · 100d
Cleared Jun 11, 2008
SATURN 9000-810
K080589 · MQB
New Medical Co., Ltd.
Radiology · 100d
Cleared Jun 11, 2008
MODEIFICATION TO IPLAN RT DOSE
K080888 · MUJ
Brainlab AG
Radiology · 72d
Cleared Jun 11, 2008
USHIFU STEPPER
K080970 · ITX
Ushifu Development Company, LLC
Radiology · 68d
Cleared Jun 11, 2008
PRECISION 500D R&F X-RAY SYSTEM
K081091 · JAA
Ge Healthcare
Radiology · 56d
Cleared Jun 11, 2008
21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)
K081242 · LLZ
Tokotu Electric Co., Ltd.
Radiology · 41d
Cleared Jun 11, 2008
ALZ WEB PACS, VERSION 1.0
K081304 · LLZ
Alz, Inc.
Radiology · 34d
Cleared Jun 11, 2008
MODIFICATION TO INREACH SYSTEM
K081379 · JAK
Superdimension, Ltd.
Radiology · 26d
Cleared Jun 11, 2008
CSBP-001A BODY ORGAN PERFUSION SYSTEM
K081482 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jun 06, 2008
ERGO++ VERSION 1.7
K080601 · MUJ
3D Line Medical Systems S.R.L.
Radiology · 95d