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
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
1–24 of 130
Cleared Aug 28, 2023
QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)
K230221
Versant Medical Physics and Radiation Safety
Radiology · 214d
Cleared Feb 22, 2023
3D-RD-S
K212587
Radiopharmaceutical Imaging and Dosimetry, LLC
Radiology · 555d
Cleared Jul 19, 2017
OLINDA EXM
K163687
Hermes Medical Solutions AB
Radiology · 203d
Cleared Nov 18, 2016
Discovery NM 750b Bopsy
K160933
Ge Healthcare
Radiology · 228d
Cleared Aug 18, 2016
Sentinella 102, Sentinella 102 Horus
K162052
General Equipment For Medical Imaging (Oncovision-
Radiology · 24d
Cleared Nov 18, 2014
Sentinella 102
K143156
General Equipment For Medical Imaging (Oncovision-
Radiology · 15d
Cleared Jan 15, 2013
ERGO IMAGING SYSTEM
K123408
Digirad Corp.
Radiology · 71d
Cleared Sep 23, 2011
LUMAGEM MOLECULAR BREAST IMAGING SYSTEM
K111791
Gamma Medica-Ideas Incorporated
Radiology · 88d
Cleared May 03, 2011
DILON 6800 ACELLA (ACELLA)
K110384
Dilon Technologies, Inc.
Radiology · 82d
Cleared Mar 18, 2011
SENTINELLA 102
K110601
General Equipment For Medical Imaging, S.A.
Radiology · 16d
Cleared Apr 23, 2010
ERGO IMAGING SYSTEM
K100838
Digirad Corp.
Radiology · 30d
Cleared Oct 28, 2005
CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000
K052473
Inter Medical Medizintechnik GmbH
Radiology · 49d
Cleared Jun 13, 2005
ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM
K051402
Gvi Technology Partners
Radiology · 13d
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 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 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

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.