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U.S. Department of Health and Human Services

Product Classification

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Device digital image, storage and communications, non-diagnostic, laboratory information system
Regulation Description Calculator/data processing module for clinical use.
Definition Intended for clinical laboratory image storage and communications.A clinical laboratory image storage and communications device is a device that provides electronic storage and retrieval functions, and provides electronic transfer for non-diagnostic clinical laboratory images.Images are not intended for diagnostic purposes and not intended for radiological images.
Physical State The clinical laboratory image storage and communications device is composed of the necessary hardware and software for digital image capture and storage.
Technical Method Allows users to receive and store documents and non-diagnostic clinical laboratory digital images in a central repository or Laboratory Information System (LIS). It will allow users to scan any document for storage or retrieval and may incorporate OCR indexing technology. The system allows users to capture clinical laboratory images from a variety of methods including digital cameras attached to a microscope; digital image imported from other media and may be linked to a patient record.
Target Area In Vitro
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeNVV
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(K) Exempt
Regulation Number 862.2100
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    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.
Third Party Review Not Third Party Eligible
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