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 Nov 18, 2016
Discovery NM 750b Bopsy
K160933
Ge Healthcare
Radiology · 228d
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 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 May 28, 1992
ADAC S315
K921296
Adac Laboratories
Radiology · 72d
Cleared Jul 03, 1991
NEUROCAM
K910967
GE Medical Systems
Radiology · 119d
Cleared Jun 21, 1991
MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM
K905074
Siemens Gammasonics, Inc.
Radiology · 224d
Cleared Mar 25, 1991
ES/ULTRA DISPLAY AND PROCESSING STATION
K905412
Toshiba America Medical Systems, In.C
Radiology · 112d
Cleared Jan 04, 1991
STARCAM 4000
K904174
General Electric Co.
Radiology · 116d
Cleared Dec 05, 1990
MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA
K904050
Philips Medical Systems (Cleveland), Inc.
Radiology · 92d
Cleared Apr 19, 1990
MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA
K900689
Adac Laboratories
Radiology · 65d
Cleared Apr 17, 1989
APEX 115 NUCLEAR MEDICINE PROCESSOR
K884672
Elscint, Inc.
Radiology · 160d
Cleared Apr 17, 1989
APEX 415 ANGER CAMERA
K884674
Elscint, Inc.
Radiology · 160d
Cleared Apr 17, 1989
APEX 609R ANGER CAMERA
K884675
Elscint, Inc.
Radiology · 160d
Cleared Apr 14, 1989
APEX 215M MOBILE ANGER CAMERA
K884673
Elscint, Inc.
Radiology · 157d
Cleared Mar 30, 1989
MICRODELTA II
K885242
Siemens Gammasonics, Inc.
Radiology · 98d

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.