510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970005Substantially Equivalent

Gyrex 2T-Prestige

Elscint, Inc., Hackensack NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970005 is the FDA 510(k) clearance record for GYREX 2T-PRESTIGE, a class II device, cleared for Elscint, Inc. on under FDA product code LNI (System, Nuclear Magnetic Resonance Spectroscopic). FDA records list 94 510(k) clearances for Elscint, Inc., from to . As of , FDA records show no recalls naming K970005.

Clearance record

Decision date
Received
(85 days to decision)
Product code
LNI System, Nuclear Magnetic Resonance Spectroscopic
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Elscint, Inc. 505 Main St., Hackensack NJ
510(k) summary
Summary
Third party review
No

Clearances, product code LNI

Trailing 12 months

FDA records hold no clearances under product code LNI in the trailing twelve months.

FDA records show no clearances under product code LNI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LNI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260