GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP— 510(k) K980306
Substantially EquivalentElscint, Inc.
FDA 510(k) clearance K980306 for GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP, Substantially Equivalent on 1998-04-02. Applicant: Elscint, Inc.. Device class: 2.
Clearance details
- Applicant
- Elscint, Inc.
- Product code
- Code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hackensack, NJ, US
Recent devices under product code LNH
view allMore clearances from Elscint, Inc.
view all- K983313 — ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
- K982060 — VOLUMAX CT IMAGING SYSTEM
- K974344 — CT SCOPE
- K974614 — GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102
- K972592 — 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
Adverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.