CT SCOPE— 510(k) K974344
Substantially EquivalentElscint, Inc.
FDA 510(k) clearance K974344 for CT SCOPE, Substantially Equivalent on 1998-06-03. Applicant: Elscint, Inc.. Device class: 2.
Clearance details
- Applicant
- Elscint, Inc.
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hackensack, NJ, US
Recent devices under product code JAK
view allMore clearances from Elscint, Inc.
view all- K983313 — ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
- K982060 — VOLUMAX CT IMAGING SYSTEM
- K980306 — GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP
- 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 JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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.