Elscint, Inc.: FDA filings under this applicant name
FDA lists 94 510(k) clearances under the applicant name “Elscint, Inc.” (first 1981, latest 1998), across 20 product codes in 4 review panels. Median 510(k) review time under this name: 83 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 17 | 17 |
| JAK | System, X-Ray, Tomography, Computed | 16 | 16 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 10 | 10 |
| IZH | System, X-Ray, Mammographic | 10 | 10 |
| IYX | Camera, Scintillation (Gamma) | 5 | 5 |
| KPS | System, Tomography, Computed, Emission | 5 | 5 |
| HGL | Transducer, Ultrasonic, Obstetric | 2 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
| JOP | Transducer, Ultrasonic | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
Plus 10 more product codes.
Review panels
Most recent Elscint, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983313 | ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY | IZH | 1998-12-11 | 81 |
| K982060 | VOLUMAX CT IMAGING SYSTEM | JAK | 1998-09-02 | 83 |
| K974344 | CT SCOPE | JAK | 1998-06-03 | 196 |
| K980306 | GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP | LNH | 1998-04-02 | 65 |
| K974614 | GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 | LNH | 1998-03-04 | 83 |
| K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) | MOS | 1997-09-15 | 66 |
| K970680 | GLORY | IZH | 1997-06-20 | 116 |
| K965044 | GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 | LNH | 1997-06-16 | 185 |
| K970980 | CARDIAC SCORING FOR CT SCANNERS | JAK | 1997-05-29 | 72 |
| K970005 | GYREX 2T-PRESTIGE | LNI | 1997-03-28 | 85 |
84 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Elscint, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Elscint, Inc. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNI)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Elscint Mr, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Elscint, Inc.?
FDA lists 94 510(k) clearances under the applicant name “Elscint, Inc.” (first 1981, latest 1998), across 20 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Elscint, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Elscint, Inc. is 83 days.
Which FDA product codes appear under Elscint, Inc.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 17); JAK (System, X-Ray, Tomography, Computed, 16); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 10).
Next steps
- See all 94 Elscint, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Elscint, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.