Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Elscint, Inc. — Predicate Candidate Screening
94 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
261 days90th percentile
94clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983313 | ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY | Elscint, Inc. | 1998-12-11 | 81 | 0 |
| K982060 | VOLUMAX CT IMAGING SYSTEM | Elscint, Inc. | 1998-09-02 | 83 | 0 |
| K974344 | CT SCOPE | Elscint, Inc. | 1998-06-03 | 196 | 0 |
| K980306 | GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V | Elscint, Inc. | 1998-04-02 | 65 | 0 |
| K974614 | GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0 | Elscint, Inc. | 1998-03-04 | 83 | 0 |
| K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V- | Elscint, Inc. | 1997-09-15 | 66 | 0 |
| K970680 | GLORY | Elscint, Inc. | 1997-06-20 | 116 | 0 |
| K965044 | GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEG | Elscint, Inc. | 1997-06-16 | 185 | 0 |
| K970980 | CARDIAC SCORING FOR CT SCANNERS | Elscint, Inc. | 1997-05-29 | 72 | 0 |
| K970005 | GYREX 2T-PRESTIGE | Elscint, Inc. | 1997-03-28 | 85 | 0 |
| K964583 | XRT-7.0 | Elscint, Inc. | 1997-01-17 | 63 | 0 |
| K962100 | VOLMETRIC COINCIDENCE DETECTION SYSTEM | Elscint, Inc. | 1997-01-10 | 225 | 0 |
| K963162 | QUANTEM | Elscint, Inc. | 1996-11-12 | 90 | 0 |
| K962618 | GYREX V-EP | Elscint, Inc. | 1996-09-04 | 63 | 0 |
| K961464 | SELECT/SP | Elscint, Inc. | 1996-07-03 | 77 | 3 |
| K935024 | ESI-5000 | Elscint, Inc. | 1996-06-12 | 966 | 0 |
| K960381 | MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION | Elscint, Inc. | 1996-04-29 | 94 | 0 |
| K954039 | GYREX PRIVILEGE | Elscint, Inc. | 1995-11-24 | 88 | 0 |
| K953801 | VARICAM | Elscint, Inc. | 1995-11-22 | 103 | 5 |
| K952674 | TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL | Elscint, Inc. | 1995-09-26 | 106 | 1 |
| K945791 | GYRES 2T PRESTIGE | Elscint, Inc. | 1995-09-19 | 298 | 0 |
| K941353 | MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIO | Elscint, Inc. | 1995-03-31 | 375 | 0 |
| K945512 | HRSW OPTION FOR CT TWIN FLASH | Elscint, Inc. | 1995-03-14 | 125 | 0 |
| K943320 | HEAD AND NECK COIL FOR THE GYREX 2T-DLX | Elscint, Inc. | 1994-11-29 | 141 | 0 |
| K934987 | CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX | Elscint, Inc. | 1994-09-16 | 333 | 0 |
| K935549 | GYREX 2T-SGR | Elscint, Inc. | 1994-08-24 | 280 | 0 |
| K934831 | ADVANCED AUTOMATIC KV | Elscint, Inc. | 1994-08-23 | 319 | 0 |
| K932508 | ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW | Elscint, Inc. | 1994-07-29 | 430 | 0 |
| K935224 | VOLUME NECK COIL FOR THE GYREX V-DIX | Elscint, Inc. | 1994-06-27 | 238 | 0 |
| K932673 | APEX SPX CARDIAL | Elscint, Inc. | 1994-02-18 | 261 | 1 |
| K925627 | ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT | Elscint, Inc. | 1993-10-08 | 336 | 0 |
| K925985 | GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0 | Elscint, Inc. | 1993-10-07 | 316 | 0 |
| K930282 | AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS | Elscint, Inc. | 1993-08-23 | 214 | 0 |
| K930090 | HELICAT | Elscint, Inc. | 1993-03-19 | 70 | 0 |
| K923897 | A BREAST COIL FOR THE GYREX 2T-DIX | Elscint, Inc. | 1992-10-21 | 78 | 0 |
| K915738 | EXCEL CT TWIN | Elscint, Inc. | 1992-07-21 | 214 | 0 |
| K914807 | APEX HELIX - A | Elscint, Inc. | 1992-02-27 | 125 | 1 |
| K915579 | 3D PROCESSING OPTIONS FOR GYREX | Elscint, Inc. | 1992-02-18 | 67 | 0 |
| K915601 | GYREX 2T-DLX | Elscint, Inc. | 1992-02-14 | 63 | 0 |
| K915748 | AVIVA MAMMOGRAPHIC X-RAY SYSTEM | Elscint, Inc. | 1992-02-04 | 43 | 0 |
| K915598 | SPECIAL PURPOSE COILS FOR GYREX V | Elscint, Inc. | 1992-01-31 | 49 | 0 |
| K912974 | MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM | Elscint, Inc. | 1991-09-19 | 73 | 0 |
| K904359 | ESI-3000 ULTRASOUND SYSTEM | Elscint, Inc. | 1991-03-05 | 162 | 0 |
| K903028 | GYREX 2T VERSION 2.1U. | Elscint, Inc. | 1990-09-10 | 61 | 0 |
| K900170 | MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U | Elscint, Inc. | 1990-07-25 | 194 | 0 |
| K896419 | MODEL: GYREX VERSION V | Elscint, Inc. | 1990-02-02 | 86 | 0 |
| K894542 | ELSCINT'S EXEL 2400E CT SCANNER | Elscint, Inc. | 1989-09-07 | 49 | 0 |
| K890636 | CARDIAC COMPUTATION SOFTWARE PACKAGE | Elscint, Inc. | 1989-08-07 | 180 | 0 |
| K890638 | VOLUME COMPUTATION SOFTWARE PACKAGE | Elscint, Inc. | 1989-08-07 | 180 | 0 |
| K890637 | EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE | Elscint, Inc. | 1989-06-12 | 124 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda