Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)
Summary
Precision Healing, LLC received 510(k) clearance for Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009), a QJF device. Cleared on 2023-12-05.
Details
Source
510(k) Clearance
External ID
K230734
Action Date
2023-12-05
Status
Traditional
Category
device
Product Code
QJF
Product Description
Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009). Product code: QJF.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Precision Healing, LLC have FDA actions?
This is the only FDA action we have on record for Precision Healing, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K230734" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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