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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

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 the device name listed in this FDA 510(k) record. The listed applicant is Precision Healing, LLC. It received FDA 510(k) clearance on 2023-12-05 under 510(k) 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. The listed applicant is Precision Healing, LLC. The 510(k) number is K230734.

When did Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) receive FDA 510(k) clearance?

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

Who is the listed applicant for Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)?

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

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.

Related Devices (Code: QJF)

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.

Official Source

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