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510(k) K173507

Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 by Philips Healthcare (Suzhou) Co., Ltd. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2018
Date Received
November 13, 2017
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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  • K223311 — Philips CT 3500 (December 22, 2022)
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  • K212864 — dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T (December 1, 2021)
  • K211168 — Philips Incisive CT on Trailer (November 22, 2021)
  • K203514 — Precise Position (June 17, 2021)
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