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510(k) K183606

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) by Scandidos AB — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2019
Date Received
December 26, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Scandidos AB

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  • K151426 — ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ (January 29, 2016)
  • K151180 — ScandiDos Delta4 Phantom+ (August 19, 2015)
  • K052920 — DELTA4 (January 12, 2006)

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