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510(k) K113748

IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) by Imris, Inc. — Product Code HBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2012
Date Received
December 21, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Head, Neurosurgical (Skull Clamp)
Device Class
Class II
Regulation Number
882.4460
Review Panel
NE
Submission Type

Other clearances by Imris, Inc.

  • K143420 — SYMBIS Surgical System (October 30, 2015)
  • K141950 — HFD100 ROCKER ARM ACCESSORY (September 4, 2014)
  • K133692 — IMRI 1.5T AND IMRI 3T S (February 10, 2014)
  • K130224 — ICT (July 18, 2013)
  • K123091 — VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T (December 27, 2012)
  • K121997 — IMRIS ONCOLOGY PACKAGE (August 10, 2012)
  • K103493 — HEAD FIATION DEVICE (HFD 100) (March 11, 2011)
  • K103506 — 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) (February 2, 2011)
  • K101813 — IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO (October 5, 2010)
  • K091166 — IMRX (September 2, 2009)

Other clearances for product code HBL

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  • K240319 — DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101. (April 24, 2024)
  • K203505 — DORO QR3 Headrest System (Aluminum) (March 29, 2021)
  • K193438 — DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable S (June 2, 2020)
  • K191740 — DORO LUCENT® iXI and iMRI Headrest System (February 21, 2020)
  • K191701 — Arcus Head Fixation Frame (November 15, 2019)
  • K191979 — DORO QR3 XTom Headholder System (October 22, 2019)
  • K163322 — TZ SKULL PIN Adult (February 23, 2017)
  • K142238 — MAYFIELD Skull Clamp (November 24, 2014)