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U.S. Department of Health and Human Services

Product Classification

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Device evoked photon image capture device
Regulation Description Evoked photon image capture device.
Definition The System reports two sets of numbers under two different conditions, one with capacitive barrier to minimize the effect of variables such as oils and sweat on the image and one without the capacitive barrier. The response scale reports numerical measures of electrophysiological signals emanating from the skin. The device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions. This device is only to be used to image and document electrophysiological signals emanating from the skin.
Physical State The system includes the following components: (1) The Device, (2) Power cord, (3) USB external cable, (4) Electrode cover, (5) Finger shroud, (6) Reference probe, (7) Reference probe cable, (8) Reference probe shroud, (9) Instructions for Use, (10) Computer All-In-One System or Laptop with Software installed, (11) Keyboard and mouse, (12) USB hardware key, (13) Capacitive barriers, (14) Cleaning cloths, and (15) Alcohol swabs
Technical Method The System consists of the hardware attached to a computer/software system. The measurements are digital photographs acquired when placing a fingertip in contact with a glass electrode. A series of electrical impulses are applied to the glass electrode generating a localized electromagnetic field around the fingertip. Under the influence of this field, an image is generated.
Target Area Finger tips
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePNA
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(K) Exempt
Regulation Number 882.1561
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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