GammaTile— 510(k) K190296

Substantially Equivalent

Gt Medical Technologies

FDA 510(k) clearance K190296 for GammaTile, Substantially Equivalent on 2019-03-13. Applicant: Gt Medical Technologies. Device class: 2.

Clearance details

Applicant: Gt Medical Technologies
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2019-02-11
Decision date: 2019-03-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

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K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles2020-12-31

More clearances from Gt Medical Technologies

K190839 — GammaTile2020-01-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.