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kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompa…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K152321

by Qfix

Identifiers

510(k) Number
K152321 FDA 510(k)
FDA Product Code
IYE FDA 510(k)
Models / Variants
Encompass MRI Device FDA 510(k)
Encompass Intracranial Fibreplast Variable Perf Head Only Open View System FDA 510(k)
Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5050 FDA 510(k)
Regulation Number
892.5050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompa… by Qfix — Class II — FDA_510K — listed in FDA 510(k) — 3 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Qfix

Sources (1)

  • FDA 510(k) K152321 24 fields · synced Jun 18, 2026