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 Nov 03, 2010
DISCOVERY NM 750B
K102231
Ge Medical Systems Israel, Functional Imaging
Radiology · 86d
Cleared Aug 04, 2010
SCANDIA-45 GAMMA CAMERA SYSTEM
K101391
Scandia Corporation
Radiology · 78d
Cleared Apr 23, 2010
ERGO IMAGING SYSTEM
K100838
Digirad Corp.
Radiology · 30d
Cleared Apr 02, 2010
PROXISCAN MODEL 101
K093706
Hybridyne Imaging Technologies, Inc.
Radiology · 122d
Cleared Dec 11, 2009
GAMMALOC SYSTEM, MODEL 03-00001
K082588
Dilon Technologies, LLC
Radiology · 459d
Cleared Oct 02, 2009
MODEL SENTINELLA 102
K092471
General Equipment For Medical Imaging, S.A.
Radiology · 52d
Cleared Aug 15, 2008
VERISTA IMAGING ISOCAM II GAMMA CAMERA
K081757
Verista Imaging, Inc.
Radiology · 56d
Cleared Jul 11, 2008
CAPIMAGE
K081829
Danish Diagnostic Development A/S
Radiology · 14d
Cleared Dec 20, 2007
T-QUEST SYSTEM
K073456
Medx, Inc.
Radiology · 10d
Cleared Jun 20, 2007
KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5
K071195
Ani-Kal Ii, LLC
Radiology · 51d
Cleared Sep 13, 2006
MAMMOPAD RADIOLUCENT CUSHION
K062141
Biolucent, Inc.
Radiology · 48d
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 Jun 15, 2004
OLINDA/EXM
K033960
Vanderbilt University
Radiology · 176d

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.