FDA 510(k) Radiology Devices
FDA 510(k) Radiology Devices - Regulatory Overview
FDA 510(k) radiology devices include medical imaging systems and radiation therapy equipment. The FDA review panel code is RA.
Key modalities covered:
- X-ray and fluoroscopy - digital radiography, fluoroscopy systems and C-arms
- Computed tomography (CT) - whole-body and dedicated CT scanners
- Magnetic resonance imaging (MRI) - 1.5T, 3T and extremity MRI systems
- Ultrasound imaging - diagnostic, point-of-care and intravascular ultrasound
- Radiation therapy - linear accelerators, brachytherapy and treatment planning
- Nuclear medicine - PET, SPECT and gamma camera systems
15507
Total
15488
Cleared
146d
Avg (2y)
1976
Since
4789 Radiology devices
Cleared
Oct 30, 1987
KODAK SV6500 PRINTER/ SV65 FINISHER/ SV100 SET
LMB
Device, Digital Image Storage, Radiological
87d
Cleared
Sep 23, 1987
CT PACE CATALOG NUMBER B7950A
JAK
System, X-ray, Tomography, Computed
90d
Cleared
Sep 08, 1987
VOLUMETRIC PACKAGE STEPPER H4222AA/CALCU. H4222AB
IYO
System, Imaging, Pulsed Echo, Ultrasonic
84d
Cleared
Aug 27, 1987
KODAK MIN-R MEDIUM SCREEN
EAM
Screen, Intensifying, Radiographic
16d
Cleared
Aug 12, 1987
KODAK EKTASCAN IMAGE TRANS. T1/R1 & P1 SOFTWARE
LMD
System, Digital Image Communications, Radiological
82d
Cleared
Aug 12, 1987
CT9800 QUICK 3D #B7919DA
JAK
System, X-ray, Tomography, Computed
91d
Cleared
Jul 01, 1987
POLYTRON MODELS 1001, 1002 AND 1004
LLZ
System, Image Processing, Radiological
120d
Cleared
Jun 22, 1987
LP LATERAL FLUORO POSITIONER (B5077A)
JAA
System, X-ray, Fluoroscopic, Image-intensified
25d
Cleared
Jun 19, 1987
PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM
IXC
Illuminator, Radiographic-film
8d
Cleared
Jun 19, 1987
OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER
KXJ
Table, Radiologic
39d
Cleared
Jun 18, 1987
SCX INFORMATION MANAGEMENT SYSTEM
KPR
System, X-ray, Stationary
136d
Cleared
Mar 23, 1987
7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12
ITX
Transducer, Ultrasonic, Diagnostic
181d
Cleared
Mar 09, 1987
BONE MINERAL DENSITOMETRY OPTION B7918AA
KGI
Densitometer, Bone
174d
Cleared
Mar 04, 1987
SERIES 620 RECTAL PROBE COVER
ITX
Transducer, Ultrasonic, Diagnostic
127d
Cleared
Feb 26, 1987
KODAK X-OMATIC IDENTIFICATION CAMERA DIGITAL
JAC
System, X-ray, Film Marking, Radiographic
6d
Cleared
Feb 26, 1987
KODAK X-OMATIC IDENT. CAMERA, MODELS 2 AND 2L
JAC
System, X-ray, Film Marking, Radiographic
16d
Cleared
Feb 11, 1987
KODAK EKTASCAN IMAGE TRANS SYS T1/R1 SOFTWARE,1.10
LLZ
System, Image Processing, Radiological
69d
Cleared
Feb 11, 1987
KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM P1
LLZ
System, Image Processing, Radiological
69d
Cleared
Feb 10, 1987
RT2800(115V)/H4008C AND RT2800(220/240V)/H4008CE
ITX
Transducer, Ultrasonic, Diagnostic
140d
Cleared
Jan 14, 1987
DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE
LLZ
System, Image Processing, Radiological
152d
Cleared
Jan 02, 1987
ULTRASOUND TRANSDUCER ASSEMBLY
ITX
Transducer, Ultrasonic, Diagnostic
206d
Cleared
Nov 26, 1986
TELERADIOGRAPHY SYSTEM
LMD
System, Digital Image Communications, Radiological
128d
Cleared
Nov 25, 1986
7.5 MHZ LINEAR PROBE, CAT. NO. H4221H
ITX
Transducer, Ultrasonic, Diagnostic
119d
Cleared
Nov 24, 1986
7.5 MHZ LINEAR SMALL PARTS PROBE
IYO
System, Imaging, Pulsed Echo, Ultrasonic
88d
Cleared
Nov 10, 1986
5.O MHZ SECTOR PROBE, MODEL 8818106 LH 307
IYO
System, Imaging, Pulsed Echo, Ultrasonic
89d
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