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FDA 510(k)

Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)

K-Number: K230734 · 2023-12-05

ApplicantPrecision Healing, LLC
Decision Date2023-12-05
Product CodeQJF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) is a medical device manufactured by Precision Healing, LLC. It received FDA 510(k) clearance on 2023-12-05 under approval number K230734. The device is classified under product code QJF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)?

Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) is a medical device that received FDA 510(k) clearance on 2023-12-05. It is manufactured by Precision Healing, LLC. The 510(k) number is K230734.

When was Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) approved by the FDA?

Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) received FDA 510(k) clearance on 2023-12-05, under approval number K230734.

What company makes Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)?

Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) is manufactured by Precision Healing, LLC.

What is the FDA product code for Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)?

The FDA product code for Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) is QJF.

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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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