HEAD FIATION DEVICE (HFD 100)— 510(k) K103493

Clearance details

Applicant

Imris, Inc.

Product code

Code HBL

Device class

Class 2

Regulation

21 CFR 882.4460

Advisory panel

Neurology

Date received

2010-11-29

Decision date

2011-03-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rockville, MD, US

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• K143420 — SYMBIS Surgical System2015-10-30
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• K133692 — IMRI 1.5T AND IMRI 3T S2014-02-10
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Death

3

Injury

753

Malfunction

1,421

Total

2,177

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1034-2026 — Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component.Class II·Ongoing·IMRIS Imaging Inc·20251208
• Z-0934-2022 — Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.Class II·Terminated·Deerfield Imaging, Inc.·20220217
• Z-3211-2017 — IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screwClass II·Terminated·Deerfield Imaging·20170814

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103493.