Elscint, Inc.
Medical device manufacturer in Rockleigh, NJ.
94510(k) clearances
0PMA approvals
0recalls
Device types
- LNH System, Nuclear Magnetic Resonance Imaging 17
- JAK System, X-Ray, Tomography, Computed 16
- IZH System, X-Ray, Mammographic 10
- IYO System, Imaging, Pulsed Echo, Ultrasonic 10
- KPS System, Tomography, Computed, Emission 5
- IYX Camera, Scintillation (Gamma) 5
- IYN System, Imaging, Pulsed Doppler, Ultrasonic 2
- HGL Transducer, Ultrasonic, Obstetric 2
- JOP Transducer, Ultrasonic 2
- IZO Generator, High-Voltage, X-Ray, Diagnostic 1
- MOS Coil, Magnetic Resonance, Specialty 1
- LNI System, Nuclear Magnetic Resonance… 1
- HEM Imager, Ultrasonic Obstetric-Gynecologic 1
- FCG Biopsy Needle 1
- DPS Electrocardiograph 1
- IZL System, X-Ray, Mobile 1
- IYP Phantom, Anthropomorphic, Nuclear 1
- IZI System, X-Ray, Angiographic 1
- IZF System, X-Ray, Tomographic 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K983313 | Advanced Automatic Detector Selection Option for GloryIZH · Traditional | 12/11/1998SE |
| K982060 | Volumax CT Imaging SystemJAK · Traditional | 09/02/1998SE |
| K974344 | CT ScopeJAK · Traditional | 06/03/1998SE |
| K980306 | Gyrex 2T Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-EpLNH · Traditional | 04/02/1998SE |
| K974614 | Gyrex 2T Prestige 100-6321-0107, Gyrex Priviledge 100-6326-0102, Gyrex Prima 1TG…LNH · Traditional | 03/04/1998SE |
| K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)MOS · Traditional | 09/15/1997SE |
| K970680 | GloryIZH · Traditional | 06/20/1997SE |
| K965044 | Gyrex 2T Prestige Model No. 100-6321-0107 and Gyrex Privilege Model No. 100-6326-0102LNH · Traditional | 06/16/1997SE |
| K970980 | Cardiac Scoring for CT ScannersJAK · Traditional | 05/29/1997SE |
| K970005 | Gyrex 2T-PRESTIGELNI · Traditional | 03/28/1997SE |
| K964583 | XRT-7.0JAK · Traditional | 01/17/1997SE |
| K962100 | Volmetric Coincidence Detection SystemKPS · Traditional | 01/10/1997SE |
| K963162 | QuantemKPS · Traditional | 11/12/1996SE |
| K962618 | Gyrex V-EpLNH · Traditional | 09/04/1996SE |
| K961464 | Select/SpJAK · Traditional | 07/03/1996SE |
| K935024 | ESI-5000IYN · Traditional | 06/12/1996SE |
| K960381 | MAM-CH22S with Automatic Filter Selection OptionIZH · Traditional | 04/29/1996SE |
| K954039 | Gyrex PrivilegeLNH · Traditional | 11/24/1995SE |
| K953801 | VaricamKPS · Traditional | 11/22/1995SE |
| K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma CameraKPS · Traditional | 09/26/1995SE |
| K945791 | Gyres 2T PrestigeLNH · Traditional | 09/19/1995SE |
| K941353 | MAM-CH22S Mammography System with Optional Mammoguide Steriotactic Biopsy SystemIZH · Traditional | 03/31/1995SE |
| K945512 | HRSW Option for CT Twin FlashJAK · Traditional | 03/14/1995SE |
| K943320 | Head and Neck Coil for the Gyrex 2T-DLXLNH · Traditional | 11/29/1994SE |
| K934987 | Cp-Spine Coils for Gyrex 2T-DLX & V-DlxLNH · Traditional | 09/16/1994SE |
| K935549 | Gyrex 2T-SGRLNH · Traditional | 08/24/1994SE |
| K934831 | Advanced Automatic KVIZH · Traditional | 08/23/1994SE |
| K932508 | Angioct Option for Ct-Twin, Helicat & OmniviewJAK · Traditional | 07/29/1994SE |
| K935224 | Volume Neck Coil for the Gyrex V-DixLNH · Traditional | 06/27/1994SE |
| K932673 | Apex SPX CardialIYX · Traditional | 02/18/1994SE |
| K925627 | Additional Features ESI-3000 Ultrasound UnitIYO · Traditional | 10/08/1993SE |
| K925985 | Gyrex V-Dix & 2T-DIX Software Version 3.0LNH · Traditional | 10/07/1993SE |
| K930282 | Aviva F22/MAM-CH22 W/Optional Cytoguide Biopsy SysIZH · Traditional | 08/23/1993SE |
| K930090 | HelicatJAK · Traditional | 03/19/1993SE |
| K923897 | A Breast Coil for the Gyrex 2T-DIXLNH · Traditional | 10/21/1992SE |
| K915738 | Excel CT TwinJAK · Traditional | 07/21/1992SE |
| K914807 | Apex Helix - aKPS · Traditional | 02/27/1992SE |
| K915579 | 3D Processing Options for GyrexLNH · Traditional | 02/18/1992SE |
| K915601 | Gyrex 2T-DLXLNH · Traditional | 02/14/1992SE |
| K915748 | Aviva Mammographic X-Ray SystemIZH · Traditional | 02/04/1992SE |
| K915598 | Special Purpose Coils for Gyrex VLNH · Traditional | 01/31/1992SE |
| K912974 | MAM-3RM-A Mammographic X-Ray SystemIZH · Traditional | 09/19/1991SE |
| K904359 | ESI-3000 Ultrasound SystemIYN · Traditional | 03/05/1991SE |
| K903028 | Gyrex 2T Version 2.1U.LNH · Traditional | 09/10/1990SE |
| K900170 | Modified Exel 2400 Elite/U & Exel 2400E/UJAK · Traditional | 07/25/1990SE |
| K896419 | Model: Gyrex Version VLNH · Traditional | 02/02/1990SE |
| K894542 | Elscint's Exel 2400E CT ScannerJAK · Traditional | 09/07/1989SE |
| K890638 | Volume Computation Software PackageJOP · Traditional | 08/07/1989SE |
| K890636 | Cardiac Computation Software PackageJOP · Traditional | 08/07/1989SE |
| K890637 | Extended Obstetrics Software Computation PackageHEM · Traditional | 06/12/1989SE |
| K884675 | Apex 609R Anger CameraIYX · Traditional | 04/17/1989SE |
| K884674 | Apex 415 Anger CameraIYX · Traditional | 04/17/1989SE |
| K884672 | Apex 115 Nuclear Medicine ProcessorIYX · Traditional | 04/17/1989SE |
| K884673 | Apex 215M Mobile Anger CameraIYX · Traditional | 04/14/1989SE |
| K890327 | Biopsy Needle Guide AttachmentFCG · Traditional | 03/08/1989SE |
| K884671 | Exel 2400 and 2400 Elite CT ScannersJAK · Traditional | 01/18/1989SE |
| K884670 | Exel 1800 and 1800E CT ScannerJAK · Traditional | 01/18/1989SE |
| K884678 | Esp 3-PHASE X-Ray GeneratorsIZO · Traditional | 01/17/1989SE |
| K884677 | Mam LS-3 Microfocus Mammography System W/Magnifi.IZH · Traditional | 01/06/1989SE |
| K884676 | MAM-2 Microfocus Mammography System W/Magnifi.IZH · Traditional | 01/06/1989SE |
| K884669 | Exel 2002 & 2002FS CT ScannerJAK · Traditional | 12/30/1988SE |
| K884668 | Exel 1002 CT ScannerJAK · Traditional | 12/30/1988SE |
| K884667 | Exel 905 Series CT ScannerJAK · Traditional | 12/30/1988SE |
| K874683 | The ESI-2000 Ultrasound UnitIYO · Traditional | 04/18/1988SE |
| K880219 | Transrectal Probe BD65S-TRIYO · Traditional | 03/31/1988SE |
| K863797 | Biopsy Needle Guide AttachmentHGL · Traditional | 03/27/1987SE |
| K870964 | ESI-1002 System and DC100S/C50M-P TransducerIYO · Traditional | 03/13/1987SE |
| K862553 | ECG ModuleDPS · Traditional | 11/07/1986SE |
| K861371 | Transvaginal Probe, Model ED65M-TVHGL · Traditional | 07/14/1986SE |
| K862118 | Model MBA-130 Mobile X-Ray SystemIZL · Traditional | 06/16/1986SE |
| K860081 | Esi 2000 Diagnostic Ultrasound System TransducersIYO · Traditional | 06/16/1986SE |
| K854959 | Linear Scanner Probe, Model TL-50IYO · Traditional | 06/16/1986SE |
| K850580 | Diagnostic Ultrasound Sys Model ULS1000IYO · Traditional | 04/03/1985SE |
| K844189 | Linear Scanner Probe Elscint Ltd. TL-35IYP · Traditional | 02/25/1985SE |
| K840451 | Biopsy Attachment;Dynex Ultrasound-IYO · Traditional | 05/09/1984SE |
| K834496 | Isorex LS-36IZI · Traditional | 02/21/1984SE |
| K834285 | KC 100 MIYO · Traditional | 02/17/1984SE |
| K834288 | Digitilt LS-30 Remote ControlIZF · Traditional | 12/29/1983SE |
| K837355 | Unknown · Traditional | 06/28/1983SE |
| K837084 | Ultrasound Equipment Model SDL-100A · Traditional | 04/28/1983SE |
| K837351 | Exoscope LS-53 · Traditional | 04/21/1983SE |
| K837353 | Floatex LS-22 · Traditional | 04/13/1983SE |
| K837352 | Ceilex LS-15/ALLMEC Argostat · Traditional | 04/13/1983SE |
| K837181 | Eminex LS-8 System · Traditional | 04/01/1983SE |
| K837178 | Standex System · Traditional | 03/22/1983SE |
| K837183 | Hi-Lo Radiological Stretcher · Traditional | 03/17/1983SE |
| K837182 | Tomax LS-20 · Traditional | 03/17/1983SE |
| K837180 | Trephix Three Phse Generators and Exonon Single Phase Generators · Traditional | 03/17/1983SE |
| K837179 | Taurus LS Three-Phase Generators · Traditional | 03/17/1983SE |
| K837177 | Controllex LS-5 · Traditional | 03/17/1983SE |
| K837176 | Exor LS-24 · Traditional | 03/17/1983SE |
| K837175 | Armex LS-51 · Traditional | 03/17/1983SE |
| K827744 | Dynex Ultrasound Diagnostic Scanner · Traditional | 10/07/1982SE |
| K812014 | DYNEX-44 Diagnostic Ultrasound ImagingIYO · Traditional | 09/16/1981SE |