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510(k) K153324

Ingenia 1.5T and Ingenia 1.5T S R5.2 by Philips Medical Systems Nederlands B.V. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2016
Date Received
November 18, 2015
Clearance Type
Abbreviated
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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  • K181966 — SmartPerfusion (August 17, 2018)
  • K162025 — IntelliSpace Portal Platform (October 18, 2016)
  • K143128 — mDIXON XD (March 20, 2015)

Other clearances for product code LNH

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  • K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/Q (February 23, 2026)
  • K260265 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (February 23, 2026)
  • K253780 — SIGNA™ Bolt (February 6, 2026)
  • K253779 — SIGNA™ Sprint Select (February 5, 2026)
  • K253499 — Ascent3T Neonatal Magnetic Resonance Imaging System (January 26, 2026)
  • K252379 — AIR Recon DL (December 23, 2025)
  • K252838 — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETO (December 19, 2025)