Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)
FDA 510(k) clearance K230734 · decided 2023-12-05
Clearance details
- K-number
- K230734
- Device name
- Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)
- Applicant
- Precision Healing, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-03-16
- Decision date
- 2023-12-05
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- QJF
- Device class
- 2
- Regulation number
- 878.4550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.