Elscint, Inc.
Mchenry, IL, US
Elscint, Inc. appears in FDA device records in Mchenry, IL. FDA records list 94 510(k) clearances between and , 3 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 94
- PMA records
- 3
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 94FDA records hold 94 510(k) clearances for Elscint, Inc. between 1981 and 1998. The busiest year on record is 1983, with 15. The most recent is 1998, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 15 |
| 1984 | 3 |
| 1985 | 2 |
| 1986 | 5 |
| 1987 | 2 |
| 1988 | 5 |
| 1989 | 14 |
| 1990 | 3 |
| 1991 | 2 |
| 1992 | 7 |
| 1993 | 4 |
| 1994 | 7 |
| 1995 | 6 |
| 1996 | 5 |
| 1997 | 7 |
| 1998 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K983313 | ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY | IZH | Substantially Equivalent | |
| K982060 | VOLUMAX CT IMAGING SYSTEM | JAK | Substantially Equivalent | |
| K974344 | CT SCOPE | JAK | Substantially Equivalent | |
| K980306 | GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP | LNH | Substantially Equivalent | |
| K974614 | GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 | LNH | Substantially Equivalent | |
| K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) | MOS | Substantially Equivalent | |
| K970680 | GLORY | IZH | Substantially Equivalent | |
| K965044 | GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 | LNH | Substantially Equivalent | |
| K970980 | CARDIAC SCORING FOR CT SCANNERS | JAK | Substantially Equivalent | |
| K970005 | GYREX 2T-PRESTIGE | LNI | Substantially Equivalent | |
| K964583 | XRT-7.0 | JAK | Substantially Equivalent | |
| K962100 | VOLMETRIC COINCIDENCE DETECTION SYSTEM | KPS | Substantially Equivalent | |
| K963162 | QUANTEM | KPS | Substantially Equivalent | |
| K962618 | GYREX V-EP | LNH | Substantially Equivalent | |
| K961464 | SELECT/SP | JAK | Substantially Equivalent | |
| K935024 | ESI-5000 | IYN | Substantially Equivalent | |
| K960381 | MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION | IZH | Substantially Equivalent | |
| K954039 | GYREX PRIVILEGE | LNH | Substantially Equivalent | |
| K953801 | VARICAM | KPS | Substantially Equivalent | |
| K952674 | TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA | KPS | Substantially Equivalent | |
| K945791 | GYRES 2T PRESTIGE | LNH | Substantially Equivalent | |
| K941353 | MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM | IZH | Substantially Equivalent | |
| K945512 | HRSW OPTION FOR CT TWIN FLASH | JAK | Substantially Equivalent | |
| K943320 | HEAD AND NECK COIL FOR THE GYREX 2T-DLX | LNH | Substantially Equivalent | |
| K934987 | CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX | LNH | Substantially Equivalent | |
| K935549 | GYREX 2T-SGR | LNH | Substantially Equivalent | |
| K934831 | ADVANCED AUTOMATIC KV | IZH | Substantially Equivalent | |
| K932508 | ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW | JAK | Substantially Equivalent | |
| K935224 | VOLUME NECK COIL FOR THE GYREX V-DIX | LNH | Substantially Equivalent | |
| K932673 | APEX SPX CARDIAL | IYX | Substantially Equivalent | |
| K925627 | ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT | IYO | Substantially Equivalent | |
| K925985 | GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0 | LNH | Substantially Equivalent | |
| K930282 | AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS | IZH | Substantially Equivalent | |
| K930090 | HELICAT | JAK | Substantially Equivalent | |
| K923897 | A BREAST COIL FOR THE GYREX 2T-DIX | LNH | Substantially Equivalent | |
| K915738 | EXCEL CT TWIN | JAK | Substantially Equivalent | |
| K914807 | APEX HELIX - A | KPS | Substantially Equivalent | |
| K915579 | 3D PROCESSING OPTIONS FOR GYREX | LNH | Substantially Equivalent | |
| K915601 | GYREX 2T-DLX | LNH | Substantially Equivalent | |
| K915748 | AVIVA MAMMOGRAPHIC X-RAY SYSTEM | IZH | Substantially Equivalent | |
| K915598 | SPECIAL PURPOSE COILS FOR GYREX V | LNH | Substantially Equivalent | |
| K912974 | MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM | IZH | Substantially Equivalent | |
| K904359 | ESI-3000 ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K903028 | GYREX 2T VERSION 2.1U. | LNH | Substantially Equivalent | |
| K900170 | MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U | JAK | Substantially Equivalent | |
| K896419 | MODEL: GYREX VERSION V | LNH | Substantially Equivalent | |
| K894542 | ELSCINT'S EXEL 2400E CT SCANNER | JAK | Substantially Equivalent | |
| K890638 | VOLUME COMPUTATION SOFTWARE PACKAGE | JOP | Substantially Equivalent | |
| K890636 | CARDIAC COMPUTATION SOFTWARE PACKAGE | JOP | Substantially Equivalent | |
| K890637 | EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE | HEM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FCGBiopsy Needle
- IYXCamera, Scintillation (Gamma)
- MOSCoil, Magnetic Resonance, Specialty
- DPSElectrocardiograph
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- HEMImager, Ultrasonic Obstetric-Gynecologic
- IYPPhantom, Anthropomorphic, Nuclear
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- LNHSystem, Nuclear Magnetic Resonance Imaging
- LNISystem, Nuclear Magnetic Resonance Spectroscopic
- KPSSystem, Tomography, Computed, Emission
- IZISystem, X-Ray, Angiographic
- IZHSystem, X-Ray, Mammographic
- IZLSystem, X-Ray, Mobile
- IZFSystem, X-Ray, Tomographic
- JAKSystem, X-Ray, Tomography, Computed
- JOPTransducer, Ultrasonic
- HGLTransducer, Ultrasonic, Obstetric
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain