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U.S. Department of Health and Human Services

Product Classification

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Device parathyroid autofluorescence imaging device
Definition An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.
Physical State The device has a non-contact image head that emits a coherent excitation light in the near-infrared spectrum and captures an autofluorescence image of the target tissues. Imaging contrast agents are not required for autofluorescence imaging.
Technical Method The imaging device is a non-contact medical device that captures autofluorescence images using a coherent excitation light source in the near-infrared spectrum.
Target Area Parathyroid glands.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQDG
Premarket Review Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4550
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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