Company ยท US
Elscint, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1998. Name variants (Inc, Corp, punctuation) are merged.
94510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 17 |
| JAK | System, X-Ray, Tomography, Computed | 16 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 10 |
| IZH | System, X-Ray, Mammographic | 10 |
| IYX | Camera, Scintillation (Gamma) | 5 |
| KPS | System, Tomography, Computed, Emission | 5 |
| HGL | Transducer, Ultrasonic, Obstetric | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 |
| JOP | Transducer, Ultrasonic | 2 |
| DPS | Electrocardiograph | 1 |
| FCG | Biopsy Needle | 1 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 1 |
| IYP | Phantom, Anthropomorphic, Nuclear | 1 |
| IZF | System, X-Ray, Tomographic | 1 |
| IZI | System, X-Ray, Angiographic | 1 |
| IZL | System, X-Ray, Mobile | 1 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 |
| LNI | System, Nuclear Magnetic Resonance Spectroscopic | 1 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 11, 1998 | K983313 | ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY Elscint, Inc. | IZH |
| Sep 2, 1998 | K982060 | VOLUMAX CT IMAGING SYSTEM Elscint, Inc. | JAK |
| Jun 3, 1998 | K974344 | CT SCOPE Elscint, Inc. | JAK |
| Apr 2, 1998 | K980306 | GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP Elscint, Inc. | LNH |
| Mar 4, 1998 | K974614 | GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 Elscint, Inc. | LNH |
| Sep 15, 1997 | K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) Elscint, Inc. | MOS |
| Jun 20, 1997 | K970680 | GLORY Elscint, Inc. | IZH |
| Jun 16, 1997 | K965044 | GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 Elscint, Inc. | LNH |
| May 29, 1997 | K970980 | CARDIAC SCORING FOR CT SCANNERS Elscint, Inc. | JAK |
| Mar 28, 1997 | K970005 | GYREX 2T-PRESTIGE Elscint, Inc. | LNI |
| Jan 17, 1997 | K964583 | XRT-7.0 Elscint, Inc. | JAK |
| Jan 10, 1997 | K962100 | VOLMETRIC COINCIDENCE DETECTION SYSTEM Elscint, Inc. | KPS |
| Nov 12, 1996 | K963162 | QUANTEM Elscint, Inc. | KPS |
| Sep 4, 1996 | K962618 | GYREX V-EP Elscint, Inc. | LNH |
| Jul 3, 1996 | K961464 | SELECT/SP Elscint, Inc. | JAK |
| Jun 12, 1996 | K935024 | ESI-5000 Elscint, Inc. | IYN |
| Apr 29, 1996 | K960381 | MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION Elscint, Inc. | IZH |
| Nov 24, 1995 | K954039 | GYREX PRIVILEGE Elscint, Inc. | LNH |
| Nov 22, 1995 | K953801 | VARICAM Elscint, Inc. | KPS |
| Sep 26, 1995 | K952674 | TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA Elscint, Inc. | KPS |
| Sep 19, 1995 | K945791 | GYRES 2T PRESTIGE Elscint, Inc. | LNH |
| Mar 31, 1995 | K941353 | MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM Elscint, Inc. | IZH |
| Mar 14, 1995 | K945512 | HRSW OPTION FOR CT TWIN FLASH Elscint, Inc. | JAK |
| Nov 29, 1994 | K943320 | HEAD AND NECK COIL FOR THE GYREX 2T-DLX Elscint, Inc. | LNH |
| Sep 16, 1994 | K934987 | CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX Elscint, Inc. | LNH |
| Aug 24, 1994 | K935549 | GYREX 2T-SGR Elscint, Inc. | LNH |
| Aug 23, 1994 | K934831 | ADVANCED AUTOMATIC KV Elscint, Inc. | IZH |
| Jul 29, 1994 | K932508 | ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW Elscint, Inc. | JAK |
| Jun 27, 1994 | K935224 | VOLUME NECK COIL FOR THE GYREX V-DIX Elscint, Inc. | LNH |
| Feb 18, 1994 | K932673 | APEX SPX CARDIAL Elscint, Inc. | IYX |
| Oct 8, 1993 | K925627 | ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT Elscint, Inc. | IYO |
| Oct 7, 1993 | K925985 | GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0 Elscint, Inc. | LNH |
| Aug 23, 1993 | K930282 | AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS Elscint, Inc. | IZH |
| Mar 19, 1993 | K930090 | HELICAT Elscint, Inc. | JAK |
| Oct 21, 1992 | K923897 | A BREAST COIL FOR THE GYREX 2T-DIX Elscint, Inc. | LNH |
| Jul 21, 1992 | K915738 | EXCEL CT TWIN Elscint, Inc. | JAK |
| Feb 27, 1992 | K914807 | APEX HELIX - A Elscint, Inc. | KPS |
| Feb 18, 1992 | K915579 | 3D PROCESSING OPTIONS FOR GYREX Elscint, Inc. | LNH |
| Feb 14, 1992 | K915601 | GYREX 2T-DLX Elscint, Inc. | LNH |
| Feb 4, 1992 | K915748 | AVIVA MAMMOGRAPHIC X-RAY SYSTEM Elscint, Inc. | IZH |
| Jan 31, 1992 | K915598 | SPECIAL PURPOSE COILS FOR GYREX V Elscint, Inc. | LNH |
| Sep 19, 1991 | K912974 | MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM Elscint, Inc. | IZH |
| Mar 5, 1991 | K904359 | ESI-3000 ULTRASOUND SYSTEM Elscint, Inc. | IYN |
| Sep 10, 1990 | K903028 | GYREX 2T VERSION 2.1U. Elscint, Inc. | LNH |
| Jul 25, 1990 | K900170 | MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U Elscint, Inc. | JAK |
| Feb 2, 1990 | K896419 | MODEL: GYREX VERSION V Elscint, Inc. | LNH |
| Sep 7, 1989 | K894542 | ELSCINT'S EXEL 2400E CT SCANNER Elscint, Inc. | JAK |
| Aug 7, 1989 | K890638 | VOLUME COMPUTATION SOFTWARE PACKAGE Elscint, Inc. | JOP |
| Aug 7, 1989 | K890636 | CARDIAC COMPUTATION SOFTWARE PACKAGE Elscint, Inc. | JOP |
| Jun 12, 1989 | K890637 | EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE Elscint, Inc. | HEM |
Newest 50 of 94.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||