FDA Product Code IYX: Camera, Scintillation (gamma)
Leading manufacturers include General Electric Co., Medtronic Vascular and Radiopharmaceutical Imaging and Dosimetry, LLC.
130
Total
130
Cleared
92d
Avg days
1976
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Camera, Scintillation (gamma) Devices (Product Code IYX)
130 devices
Cleared
Aug 28, 2023
QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)
Versant Medical Physics and Radiation Safety
Radiology
214d
Cleared
Feb 22, 2023
3D-RD-S
Radiopharmaceutical Imaging and Dosimetry, LLC
Radiology
555d
Cleared
Mar 18, 1993
UNIX-LINK
General Electric Co.
Radiology
77d
Cleared
Jan 04, 1991
STARCAM 4000
General Electric Co.
Radiology
116d
Cleared
Jan 30, 1986
STARPORT MODEL H3300AA
General Electric Co.
Radiology
223d
Cleared
Mar 01, 1985
TOMOGRAPHIC GANTRY
General Electric Co.
Radiology
121d
Cleared
Jul 06, 1984
MAXICAMERA 400 AC
General Electric Co.
Radiology
59d
Cleared
Mar 02, 1982
ADD'L TERMINAL SUPPORT FOR STAR BASIC
General Electric Co.
Radiology
32d
Cleared
Jul 02, 1981
MAXI CAMERA/D
General Electric Co.
Radiology
17d
Cleared
May 27, 1981
MEDTRONIC A2 CLINICAL IMAGING SYSTEM
Medtronic Vascular
Radiology
28d
Cleared
Nov 26, 1980
A2 IMAGE PROCESSING SYSTEM
Medtronic Vascular
Radiology
48d
Cleared
Aug 20, 1980
MAXI CAMERA 37
General Electric Co.
Radiology
33d
Cleared
Aug 20, 1980
MAXI CAMERA 61
General Electric Co.
Radiology
33d
Cleared
Jul 21, 1980
A2 IMAGE PROCESSING SYSTEM
Medtronic Vascular
Radiology
41d
Cleared
Mar 26, 1979
MODU-SET COLLIMOTOR
Medtronic Vascular
Radiology
21d
Cleared
Dec 22, 1978
MAXI CAMERA 400T
General Electric Co.
Radiology
17d
Cleared
Dec 20, 1978
PROCESSING SYSTEM, A2 IMAGE
Medtronic Vascular
Radiology
12d
Cleared
Oct 17, 1978
MAXI-CAMERA 535
General Electric Co.
Radiology
14d
Cleared
Apr 18, 1978
DATA CAMERA
General Electric Co.
Radiology
22d
Cleared
May 10, 1977
PORTA CAMERA IIC
General Electric Co.
Radiology
15d
Cleared
Feb 28, 1977
MAXICAMERA II
General Electric Co.
Radiology
10d
Cleared
Dec 06, 1976
PORTACAMERA 11-B
General Electric Co.
Radiology
7d
About Product Code IYX - Regulatory Context
510(k) Submission Activity
130 total 510(k) submissions under product code IYX since 1976, with 130 receiving FDA clearance (average review time: 92 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.