Medical device manufacturer
Elscint, Inc.
Elscint, Inc. holds 94 FDA 510(k) clearances across 19 product codes. Median elapsed review time is 83 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 94
- Product codes
- 19
- Median review
- 83 days
- Recall records
- 0
How does FDA spell Elscint, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Elscint, Inc. file in?
19 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 17 | 86 days | |
| JAK | System, X-Ray, Tomography, Computed | 16 | 71 days | |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 10 | 94 days | |
| IZH | System, X-Ray, Mammographic | 10 | 81 days | |
| IYX | Camera, Scintillation (Gamma) | 5 | 160 days | |
| KPS | System, Tomography, Computed, Emission | 5 | 106 days | |
| HGL | Transducer, Ultrasonic, Obstetric | 2 | 94 days | |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 162 days | |
| JOP | Transducer, Ultrasonic | 2 | 180 days | |
| DPS | Electrocardiograph | 1 | 127 days | |
| FCG | Biopsy Needle | 1 | 44 days | |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 1 | 124 days | |
| IYP | Phantom, Anthropomorphic, Nuclear | 1 | 118 days | |
| IZF | System, X-Ray, Tomographic | 1 | 31 days | |
| IZI | System, X-Ray, Angiographic | 1 | 75 days | |
| IZL | System, X-Ray, Mobile | 1 | 13 days | |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | 70 days | |
| LNI | System, Nuclear Magnetic Resonance Spectroscopic | 1 | 85 days | |
| MOS | Coil, Magnetic Resonance, Specialty | 1 | 66 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Elscint, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Elscint, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K983313 | ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY | IZH | 81 | |
| K982060 | VOLUMAX CT IMAGING SYSTEM | JAK | 83 | |
| K974344 | CT SCOPE | JAK | 196 | |
| K980306 | GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP | LNH | 65 | |
| K974614 | GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 | LNH | 83 | |
| K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) | MOS | 66 | |
| K970680 | GLORY | IZH | 116 | |
| K965044 | GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 | LNH | 185 | |
| K970980 | CARDIAC SCORING FOR CT SCANNERS | JAK | 72 | |
| K970005 | GYREX 2T-PRESTIGE | LNI | 85 |
Source: openFDA device/510k · retrieved
Watch what Elscint, Inc. files next
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