Lumiscope Model 1000/APCC Model 1000

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K894127 ↗

FDA Product Code

GZJ

Device Class

Class II

Regulation

21 CFR Part 882.5890

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Lumisonic

  Class II

  FDA 510(k) K924081 Active Cleared 9 Nov 1992

• Infrared Lamp

  Class II

  FDA 510(k) K925054 Active Cleared 29 Jun 1993

• Cardicare Model Mt-301F & Mt-301C

  Class II

  FDA 510(k) K032714 Active Cleared 22 Oct 2003

• Lumiscope Electrodes Models El-08, 11, 15, 06, 21, 25

  Class II

  FDA 510(k) K901809 Active Cleared 18 Jun 1990

• Lumiscope Ems 8000

  Class II

  FDA 510(k) K901849 Active Cleared 24 Aug 1990

• Interferential Current Therapy Unit

  Class II

  FDA 510(k) K931768 Active Cleared 23 Feb 1994

See all devices from Lumiscope Co., Inc. →

• What is the Lumiscope Model 1000/APCC Model 1000 primarily used for in clinical settings?

  The Lumiscope Model 1000/APCC Model 1000 is designed specifically for neurological examinations, utilizing advanced imaging techniques to visualize and assess neural structures. It aids clinicians in evaluating neurological conditions by providing detailed images of the brain and nervous system, making it a valuable tool in diagnostic workflows for neurology.

• Is the Lumiscope Model 1000/APCC Model 1000 intended for single-use or reusable applications?

  The Lumiscope Model 1000/APCC Model 1000 is supplied as a reusable medical instrument, meaning it is engineered for repeated use in clinical settings after proper cleaning, maintenance, and sterilization procedures. This design aligns with its intended use in diagnostic imaging for neurological assessments.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Lumiscope Model 1000/APCC Model 1000 received FDA clearance through the Traditional 510(k) pathway, specifically classified as Substantially Equivalent (SESE) by the Neurology Advisory Committee. This means the FDA determined that the device is at least as safe and effective as a legally marketed predicate device already on the market, ensuring its compliance with regulatory standards for neurological diagnostic imaging.

• How should I store the Lumiscope Model 1000/APCC Model 1000 when not in use?

  While the provided data does not specify storage conditions, reusable medical devices like this typically require protection from dust, moisture, and physical damage. The manufacturer’s instructions (not detailed here) should outline proper storage, including environmental controls (e.g., temperature, humidity) and handling precautions to maintain functionality and hygiene for repeated clinical use.

• Is the Lumiscope Model 1000/APCC Model 1000 compatible with MRI environments?

  The device is not specified as MRI-safe in the provided data, meaning it may not meet the strict electromagnetic compatibility or material safety standards required for use in MRI facilities. Clinicians should verify compatibility with their MRI system’s manufacturer guidelines before integrating this device into an MRI environment.