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510(k) K233629

APERTO Lucent MRI System by Fujifilm Healthcare Americas Corporation — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2024
Date Received
November 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

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  • K230752 — Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) (September 15, 2023)

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  • K253499 — Ascent3T Neonatal Magnetic Resonance Imaging System (January 26, 2026)
  • K252379 — AIR Recon DL (December 23, 2025)
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