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
9625–9648 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 17, 2000
HITACHI ALTAIRE
K002420 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Oct 17, 2000
VISION 9000 PHASED ARRAY TORSO COIL
K002482 · MOS
Usa Instruments, Inc.
Radiology · 64d
Cleared Oct 17, 2000
MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM
K002936 · LLZ
Sectra-Imtec AB
Radiology · 26d
Cleared Oct 13, 2000
FOCUS
K002147 · MUJ
Computerized Medical Systems, Inc.
Radiology · 88d
Cleared Oct 12, 2000
SOMATOM EMOTION MS
K003014 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Oct 11, 2000
MAGNETOM ALLEGRA SYSTEM
K002179 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Oct 11, 2000
SURGI-VISION URETHRAL COIL
K002345 · MOS
Surgi-Vision, Inc.
Radiology · 70d
Cleared Oct 10, 2000
LIGTHSPEED 3.0 CT SCANNER SYSTEM
K002978 · JAK
GE Medical Systems
Radiology · 15d
Cleared Oct 03, 2000
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER
K002490 · LNH
Fonar Corp.
Radiology · 50d
Cleared Sep 28, 2000
PREFERENCE TREATMENT SYSTEM
K001833 · IYE
Northwest Medical Physics Equipment,...
Radiology · 104d
Cleared Sep 28, 2000
MEDLINK DIAGNOSTIC OFFLINE WORKSTATION
K002144 · LLZ
Advanced Technology Laboratories, Inc.
Radiology · 73d
Cleared Sep 28, 2000
HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND...
K002711 · KGI
Hologic, Inc.
Radiology · 28d
Cleared Sep 28, 2000
MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
K002833 · KPT
Standard Imaging, Inc.
Radiology · 16d
Cleared Sep 27, 2000
ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART
K002039 · LLZ
Cti Pet Systems, Inc.
Radiology · 84d
Cleared Sep 27, 2000
KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY
K002146 · LMC
Eastman Kodak Company
Radiology · 72d
Cleared Sep 22, 2000
BOLUSPRO ULTRA
K002005 · JAK
Marconi Medical Systems, Inc.
Radiology · 81d
Cleared Sep 20, 2000
POLESTAR N-10
K002242 · LNH
Odin Technologies , Ltd.
Radiology · 58d
Cleared Sep 20, 2000
ALOKA UST-5280-5
K002784 · ITX
Aloka Co., Ltd.
Radiology · 14d
Cleared Sep 19, 2000
PROSTEC 125I BRANCHYTHERAPY SNAPSEED
K001366 · KXK
Prostec, LLC
Radiology · 172d
Cleared Sep 15, 2000
DS DS I-SERIES
K002553 · KPS
Smv America
Radiology · 29d
Cleared Sep 15, 2000
CORDLESS COMPACT MOBILE X-RAY SYSTEM
K002685 · IZL
Medison Radiology Systems, Inc.
Radiology · 18d
Cleared Sep 08, 2000
M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A...
K002470 · IYN
Agilent Technologies, Inc.
Radiology · 28d
Cleared Sep 07, 2000
LOOK COLLAGEN SPACERS, MODEL 1514B
K001765 · KXK
Surgical Specialties Corp
Radiology · 87d
Cleared Sep 06, 2000
GYROSCAN INTERA (R7.5)
K001796 · LNH
Philips Medical Systems North...
Radiology · 84d