VARICAM— 510(k) K953801
Substantially EquivalentElscint, Inc.
FDA 510(k) clearance K953801 for VARICAM, Substantially Equivalent on 1995-11-22. Applicant: Elscint, Inc.. Device class: 2.
Clearance details
- Applicant
- Elscint, Inc.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hackensack, NJ, US
Recent devices under product code KPS
view allMore clearances from Elscint, Inc.
view allRecalls naming K953801
K-number listed on FDA's recall record- Z-2098-2025 — Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
- Z-0900-2025 — GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Computed, Emission
- Z-0703-2019 — Discover VH/Millennium VG Nuclear Medicine Imaging System
- Z-0704-2019 — VariCam
- Z-1279-2015 — GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
- Z-1788-2013 — GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K953801.
Data sourced from openFDA. This site is unofficial and independent of the FDA.