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U.S. Department of Health and Human Services

Product Classification
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Device cranial measurement software
Regulation Description Manual surgical instrument for general use.
Definition Cranial measurement software is intended to be used to calculate and display physical measurements of the head for interpretation by a qualified user in conjunction with other clinical methods.
Physical State Software-only device for recording, storing, and analyzing images to obtain physical measurements of the head and to display measurement results. Does not include software for preparing helmets or other cranial orthosis devices, nor any clinical interpretation of the measurements.
Technical Method Uses software-based analysis of images obtained from a camera to calculate physical measurements of the head.
Target Area Head
Regulation Medical Specialty General & Plastic Surgery
Review Panel Neurology
Product CodeQQO
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(K) Exempt
Regulation Number 878.4800
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
    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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