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
9649–9672 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 20, 2000
RADIOCAMERAS EXTRACRANIAL SYSTEM
K000246 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 267d
Cleared Oct 20, 2000
WACKERS-LIU CQ SOFTWARE
K002229 · KPS
Eclipse Systems, Inc.
Radiology · 88d
Cleared Oct 20, 2000
MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS
K003121 · IYO
Medison America, Inc.
Radiology · 15d
Cleared Oct 20, 2000
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K003125 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Oct 19, 2000
VITREA 2, VERSION 2.1
K002519 · LLZ
Vital Images, Inc.
Radiology · 65d
Cleared Oct 18, 2000
PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206
K002444 · IYE
Sun Nuclear Corp.
Radiology · 70d
Cleared Oct 17, 2000
FLUOROSCAN PROFILE, MODEL TCA 4 PLUS
K002198 · OWB
Fluoro Scan Imaging Systems, Inc.
Radiology · 89d
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