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510(k) K231986

Modus IR by Synaptive Medical, Inc. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2024
Date Received
July 5, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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  • K160523 — BrightMatter Guide with BrightMatter Pointer (June 24, 2016)
  • K153281 — BrightMatter Guide with Surface Trace Registration (March 30, 2016)
  • K153284 — Synaptive ImageDrive Pro (March 29, 2016)
  • K142024 — BRIGHTMATTER NAVIGATION SYSTEM (April 2, 2015)
  • K140337 — BRIGHTMATTER PLANNING SOFTWARE (June 2, 2014)

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  • K231075 — Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (June 20, 2023)
  • K230727 — SPY Portable Handheld Imaging (SPY-PHI) System (June 5, 2023)
  • K222240 — EXPLORER AIR® II (February 28, 2023)
  • K214097 — Explorer Air II (February 25, 2022)
  • K202391 — DIR 800 (January 21, 2021)
  • K192761 — Asimov-MKS Imaging System (January 17, 2020)
  • K190772 — SURGICAL MICROSCOPE SYSTEM ORBEYE with IR (October 10, 2019)