510(k) Report

FDA applicant

Elscint, Inc.

Hackensack, NJ94 decisions1981–199814 recalls

FDA records 94 decisions for Elscint, Inc. (Hackensack, NJ) from 1981 to 1998: 94 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and JAK (System, X-Ray, Tomography, Computed). Its devices cite 32 predicates, 23 of them its own earlier devices. 14 recalls are linked to its devices, 2 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Elscint, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Elscint, Inc. since 2007.

Recalls per year

4in 2025

2012: 32013: 2, 2 Class I2015: 12017: 22024: 12025: 4
2007high 4 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Elscint, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LNHSystem, Nuclear Magnetic Resonance Imaging17decisions
  • JAKSystem, X-Ray, Tomography, Computed16decisions
  • IZHSystem, X-Ray, Mammographic10decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic10decisions
  • IYXCamera, Scintillation (Gamma)5decisions
  • KPSSystem, Tomography, Computed, Emission5decisions

Also: HGL (2), IYN (2), JOP (2), IZF (1), LNI (1), IZL (1).

Whose devices does it build on?

Its devices cite 32 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 37 times; 23 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K954039Gyrex PrivilegeElscint, Inc. · 19955cite it
  • K945791Gyres 2T PrestigeElscint, Inc. · 19955cite it
  • K945512HRSW Option for CT Twin FlashElscint, Inc. · 19954cite it
  • K961464Select/SPElscint, Inc. · 19963cite it
  • K935024ESI-5000Elscint, Inc. · 19963cite it
  • K970980Cardiac Scoring for CT ScannersElscint, Inc. · 19972cite it

What has FDA decided for it lately?

  • K983313Advanced Automatic Detector Selection Option for GloryElscint, Inc. · 1998
  • K982060Volumax CT Imaging SystemElscint, Inc. · 1998
  • K974344CT ScopeElscint, Inc. · 1998
  • K980306Gyrex 2T Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-EPElscint, Inc. · 1998
  • K974614Gyrex 2T Prestige 100-6321-0107, Gyrex Priviledge 100-6326-0102, Gyrex Prima 1TG 100-6250-0102Elscint, Inc. · 1998
  • K9725922T Prestige (100-6321-0107)/Privilege (100-6326-0102)/Gyrex V-EP (100-6327-0101)Elscint, Inc. · 1997
  • K970680GLORYElscint, Inc. · 1997
  • K965044Gyrex 2T Prestige Model NO. 100-6321-0107 and Gyrex Privilege Model NO. 100-6326-0102Elscint, Inc. · 1997

All 94 as Elscint, Inc. →

What has been recalled?

14 recalls linked to its devices; the latest:

  • K932673Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac…Sep 12, 2025Class II
  • K952674Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for…Sep 12, 2025Class II
  • K884674Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for…Sep 12, 2025Class II
  • K953801Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine SystemJun 20, 2025Class II
  • K953801GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085…Dec 18, 2024Class II
  • K953801VariCamOct 30, 2017Class II

Other applicant names beginning “Elscint”

FDA records each applicant name separately; these may or may not be the same firm.

Elscint Mr, Inc. 3