Product code IYX— Radiology
GAMMA CAMERA
- Classification name
- Camera, Scintillation (Gamma)
- Device class
- Class 1
- Regulation
- 21 CFR 892.1100
- Advisory panel
- Radiology
- Total cleared
- 130
- First cleared
- Most recent
Market context for product code IYX
FDA has cleared devices under product code IYX between 1976 and 2023, filed by 67 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2023
- 2017
- 2016
- 2014
- 2013
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
Top applicants under product code IYX
Recent clearances under product code IYX
1–100 of 130- K230221 — QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)
- K212587 — 3D-RD-S
- K163687 — OLINDA EXM
- K160933 — Discovery NM 750b Bopsy
- K162052 — Sentinella 102, Sentinella 102 Horus
- K143156 — Sentinella 102; Sentinella 102 Horus
- K123408 — ERGO IMAGING SYSTEM
- K111791 — LUMAGEM MOLECULAR BREAST IMAGING SYSTEM
- K110384 — DILON 6800 ACELLA (ACELLA)
- K110601 — SENTINELLA 102
- K102231 — DISCOVERY NM 750B
- K101391 — SCANDIA-45 GAMMA CAMERA SYSTEM
- K100838 — ERGO IMAGING SYSTEM
- K093706 — PROXISCAN MODEL 101
- K082588 — GAMMALOC SYSTEM, MODEL 03-00001
- K092471 — MODEL SENTINELLA 102
- K081757 — VERISTA IMAGING ISOCAM II GAMMA CAMERA
- K081829 — CAPIMAGE
- K073456 — T-QUEST SYSTEM
- K071195 — KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5
- K062141 — MAMMOPAD RADIOLUCENT CUSHION
- K052473 — CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000
- K051402 — ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM
- K033960 — OLINDA/EXM
- K040587 — MINI GAMMA CAMERA, MODEL MGC-500
- K023373 — ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101
- K022342 — EZ-SCOPE AN, EZ-SCOPE LIGHT
- K020643 — EZ-SCOPE AN & EZ-SCOPE AN LITE
- K003775 — PORTABLE BREAST COMPRESSION DEVICE
- K993813 — LUMAGEM SCINTILLATION CAMERA
- K984466 — DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5
- K961104 — NOTEBOOK IMAGER
- K945792 — IM512P
- K943602 — DI-2000
- K935273 — VISION FX 40 & 80 SERIES GAMMA CAMERA
- K932701 — CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS
- K932673 — APEX SPX CARDIAL
- K934766 — CARBON FIBER PALLET
- K933513 — R &D BATTERIES, INC. PART # 5015, 5192, 5482
- K933256 — FAN BEAM COLLIMATOR
- K932957 — QUANTEM (TM)
- K923180 — SPECTURN, MODEL TTK-128
- K930283 — THYRUS
- K926550 — UNIX-LINK
- K926083 — NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES
- K924639 — NEW DETECTOR FOR TRANSCAM/POLARIS S315
- K924878 — NEW DETECTOR OPTION
- K923356 — MEDX ROTATIONAL GANTRY SYSTEM
- K921296 — ADAC S315
- K910967 — NEUROCAM
- K905074 — MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM
- K911346 — SOPHYCAMERA DSX BODYTRAK
- K905412 — ES/ULTRA DISPLAY AND PROCESSING STATION
- K903469 — GAMMA 600 NUCLEAR MEDICINE COMPUTER
- K905827 — FULL VIEW OMEGA TABLE
- K904174 — STARCAM 4000
- K904050 — MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA
- K903030 — SOPHYCAMERA DSM 315
- K903988 — PANORAMIC OMEGA IMAGING TABLE
- K900773 — NUCLEAR MAX
- K900689 — MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA
- K894931 — SOPHYCAMERA DSX RECTANGULAR
- K893379 — XENOS MOBILECAM
- K885054 — SYSTEM SEVENTY SEVEN
- K884672 — APEX 115 NUCLEAR MEDICINE PROCESSOR
- K884674 — APEX 415 ANGER CAMERA
- K884675 — APEX 609R ANGER CAMERA
- K884673 — APEX 215M MOBILE ANGER CAMERA
- K884661 — D-SCOPE III
- K885242 — MICRODELTA II
- K880878 — CX250 MOBILE GAMMA CAMERA & DCS CONSOLE
- K881013 — MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A
- K882312 — MODEL 3000 NUCLEAR CAMERA
- K875198 — DIGITAL NUCLEAR IMAGING SYSTEM
- K872297 — DS-7 NUCLEAR MEDICINE GAMMA CAMERA
- K872127 — D-SCOPE II AND D-SCOPE IIC
- K871175 — JUMBO DIGITAL GAMMACAMERA, GCA-901A
- K870818 — BODYSCAN
- K870703 — SKAN D-SCOPE
- K861637 — WEIGHTED ACQUISITION MODULE
- K852648 — STARPORT MODEL H3300AA
- K853482 — ACE COMPUTER SYSTEM
- K853470 — JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2
- K852089 — SATURN NUCLEAR MEDICINE COMPUTER SYSTEM
- K851644 — SPECTRUM 150 DT
- K850463 — BASICAM COUNTER BALANCE CAMERA
- K850397 — ORBITOR II COUNTER BALANCE CAMERA
- K844218 — TOMOGRAPHIC GANTRY
- K843716 — NUCLEAR 700 MEDICINE MECHANICAL POSIT-
- K843558 — DELTANODE, MEGA DELTA, DELTA LINK-
- K843288 — KETRONIC MEDAX - N
- K841964 — MICRO DELTA & CELTAPRO
- K841906 — MAXICAMERA 400 AC
- K840052 — DIGITAL PROCESSING SYSTEM
- K833821 — INTERAD 520
- K833811 — CARDIAC CAMERA
- K832505 — IMAGE PROCESSING SYS A3
- K820244 — ADD'L TERMINAL SUPPORT FOR STAR BASIC
- K813073 — OMEGA 500 RECTANGULAR FIELD CAMERA W/SC
- K811629 — DYNA- MO
Data sourced from openFDA. This site is unofficial and independent of the FDA.