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
3217–3240 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 08, 2019
Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint...
K183186 · MOS
Shanghai United Imaging Healthcare...
Radiology · 81d
Cleared Feb 07, 2019
SonoSite SII Ultrasound System
K183235 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 79d
Cleared Feb 05, 2019
JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor
K183498 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 50d
Cleared Feb 05, 2019
JADE Mobile X-Ray
K183388 · IZL
DRGEM Corporation
Radiology · 61d
Cleared Feb 04, 2019
JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor
K183499 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 49d
Cleared Feb 01, 2019
Supria True64 Whole-Body X-Ray CT System
K183291 · JAK
Hitachi Healthcare Americas
Radiology · 67d
Cleared Feb 01, 2019
DR 800 with Tomosynthesis
K183275 · IZF
Agfa N.V.
Radiology · 70d
Cleared Feb 01, 2019
AI Rad Companion (Engine)
K183272 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Jan 31, 2019
Panoura X-ERA PF/NF/MF
K182198 · MUH
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 170d
Cleared Jan 29, 2019
X5 Series Digital Color Doppler Ultrasound System
K182648 · IYN
Sonoscape Medical Corp.
Radiology · 127d
Cleared Jan 28, 2019
Aloka Arietta 850
K183456 · IYN
Hitachi Healthcare Americas
Radiology · 46d
Cleared Jan 28, 2019
Venue GO
K183362 · IYN
GE Medical Systems Ultrasound and...
Radiology · 55d
Cleared Jan 24, 2019
ProRad 2FC and ProRad 3NC Stationary Radiographic Systems
K183541 · KPR
Prognosys Medical Systems Private...
Radiology · 35d
Cleared Jan 24, 2019
MAGNETOM Lumina
K183244 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 64d
Cleared Jan 24, 2019
E-CUBE i7
K182594 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 126d
Cleared Jan 22, 2019
O-Scan
K183685 · LNH
Esaote, S.P.A.
Radiology · 25d
Cleared Jan 22, 2019
HM70A Diagnostic Ultrasound System
K182894 · IYN
Samsung Medison Co., Ltd.
Radiology · 99d
Cleared Jan 18, 2019
Magnetom Vida
K183254 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Jan 18, 2019
SIGNA Premier
K183231 · LNH
Ge Medical Systems, LLC
Radiology · 59d
Cleared Jan 18, 2019
Pristina Serena 3D
K182951 · MUE
Ge Healthcare
Radiology · 87d
Cleared Jan 16, 2019
Carestream DRX-1 System with DRX Core Detectors
K183474 · MQB
Carestream Health, Inc.
Radiology · 30d
Cleared Jan 15, 2019
JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD...
K183497 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 29d
Cleared Jan 11, 2019
uMR 580, uMR 588
K183137 · LNH
Shanghai United Imaging Healthcare...
Radiology · 59d
Cleared Jan 11, 2019
DigitalDiagnost C90
K182973 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 77d