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FDA 510(k)

HEAD FIATION DEVICE (HFD 100)

K-Number: K103493 · 2011-03-11

ApplicantImris, Inc.
Decision Date2011-03-11
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HEAD FIATION DEVICE (HFD 100) is the device name listed in this FDA 510(k) record. The listed applicant is Imris, Inc.. It received FDA 510(k) clearance on 2011-03-11 under 510(k) number K103493. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEAD FIATION DEVICE (HFD 100)?

HEAD FIATION DEVICE (HFD 100) is a medical device that received FDA 510(k) clearance on 2011-03-11. The listed applicant is Imris, Inc.. The 510(k) number is K103493.

When did HEAD FIATION DEVICE (HFD 100) receive FDA 510(k) clearance?

HEAD FIATION DEVICE (HFD 100) received FDA 510(k) clearance on 2011-03-11, under 510(k) number K103493.

Who is the listed applicant for HEAD FIATION DEVICE (HFD 100)?

The FDA 510(k) record lists Imris, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEAD FIATION DEVICE (HFD 100)?

The FDA product code for HEAD FIATION DEVICE (HFD 100) is HBL.

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Other records listing Imris, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130224ICTK123091VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3TK121997IMRIS ONCOLOGY PACKAGEK113748IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)K1035061.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)K101813IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO

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Related Devices (Code: HBL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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