IYX · Class I · 21 CFR 892.1100

FDA Product Code IYX: Camera, Scintillation (gamma)

Leading manufacturers include General Electric Co., Siemens Gammasonics, Inc. and Adac Laboratories.

130
Total
130
Cleared
92d
Avg days
1976
Since
130 devices
25–48 of 130
Cleared May 14, 2004
MINI GAMMA CAMERA, MODEL MGC-500
K040587
Acrorad Co., Ltd.
Radiology · 70d
Cleared Jan 03, 2003
ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101
K023373
Gvi Technology Partners
Radiology · 87d
Cleared Oct 09, 2002
EZ-SCOPE AN, EZ-SCOPE LIGHT
K022342
Anzai Medical Co., Ltd.
Radiology · 83d
Cleared May 28, 2002
EZ-SCOPE AN & EZ-SCOPE AN LITE
K020643
Health Policy Resorters Group, LLC
Radiology · 90d
Cleared Jan 12, 2001
PORTABLE BREAST COMPRESSION DEVICE
K003775
Pem Technologies
Radiology · 37d
Cleared Jan 18, 2000
LUMAGEM SCINTILLATION CAMERA
K993813
Gamma Medica
Radiology · 69d
Cleared Mar 16, 1999
DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5
K984466
Dilon Technologies, Inc.
Radiology · 90d
Cleared May 28, 1997
NOTEBOOK IMAGER
K961104
Digirad Corp.
Radiology · 434d
Cleared May 24, 1995
IM512P
K945792
Globus Industries
Radiology · 180d
Cleared May 12, 1995
DI-2000
K943602
Miles Inc., Agfa Division
Radiology · 291d
Cleared Apr 18, 1994
VISION FX 40 & 80 SERIES GAMMA CAMERA
K935273
Summit Nuclear
Radiology · 167d
Cleared Mar 29, 1994
CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS
K932701
Nuccardiac Software, Inc.
Radiology · 299d
Cleared Feb 18, 1994
APEX SPX CARDIAL
K932673
Elscint, Inc.
Radiology · 261d
Cleared Feb 18, 1994
CARBON FIBER PALLET
K934766
Siemens Gammasonics, Inc.
Radiology · 137d
Cleared Nov 24, 1993
R &D BATTERIES, INC. PART # 5015, 5192, 5482
K933513
R & D Batteries, Inc.
Radiology · 127d
Cleared Oct 29, 1993
FAN BEAM COLLIMATOR
K933256
Siemens Gammasonics, Inc.
Radiology · 115d
Cleared Aug 05, 1993
QUANTEM (TM)
K932957
GE Medical Systems
Radiology · 49d
Cleared Jul 26, 1993
SPECTURN, MODEL TTK-128
K923180
Harpell Assoc., Inc.
Radiology · 391d
Cleared Jun 21, 1993
THYRUS
K930283
Adac Laboratories
Radiology · 151d
Cleared Mar 18, 1993
UNIX-LINK
K926550
General Electric Co.
Radiology · 77d
Cleared Feb 12, 1993
NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES
K926083
Biodan Medical Systems, Ltd.
Radiology · 73d
Cleared Jan 15, 1993
NEW DETECTOR FOR TRANSCAM/POLARIS S315
K924639
Adac Laboratories
Radiology · 135d
Cleared Jan 15, 1993
NEW DETECTOR OPTION
K924878
Adac Laboratories
Radiology · 136d
Cleared Sep 21, 1992
MEDX ROTATIONAL GANTRY SYSTEM
K923356
Bfi- Medical Waste Systems
Radiology · 75d