SmartScope
510(k) K932533
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK932533 | Date31 Mar 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JXE
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1550
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The SmartScope is a Nerve Conduction Velocity Measurement Device (FDA Product Code: JXE), designed to assess and evaluate peripheral nerve function. It measures the speed at which electrical impulses travel along nerves, aiding in the diagnosis of neurological conditions such as peripheral neuropathies, carpal tunnel syndrome, and other motor or sensory nerve disorders. The device provides quantitative data to support clinical assessments in neurology.
The SmartScope is intended for use in clinical settings by trained healthcare professionals, typically in neurology departments or electrodiagnostic laboratories. Supplied as a reusable medical device, it requires proper calibration and maintenance to ensure accurate measurements. The device is classified under FDA Class II and holds a FDA 510(k) clearance (K932533) with a decision date of March 31, 1994, under the regulatory framework for nerve conduction studies (regulation number 882.1550). No specific sterility or MRI safety information is provided in the available data.
Other devices from Insight Medical Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the SmartScope used for in clinical practice?
The SmartScope is designed to assess peripheral nerve function by measuring how quickly electrical impulses travel along nerves. This quantitative data helps clinicians diagnose and evaluate neurological conditions such as peripheral neuropathies, carpal tunnel syndrome, and other motor or sensory nerve disorders. It supports objective assessments in neurology departments and electrodiagnostic laboratories.
Is the SmartScope a single-use or reusable device?
The SmartScope is supplied as a reusable medical device. Since it requires regular use in clinical settings, proper calibration and maintenance are essential to ensure accurate and reliable nerve conduction measurements over time.
Does the SmartScope come with any sterility guarantees or MRI safety information?
The available data does not specify whether the SmartScope is sterile or provide any MRI safety information. Clinicians should follow standard infection control protocols and consult manufacturer guidelines for safe use in MRI environments.
What regulatory approval does the SmartScope hold?
The SmartScope holds FDA 510(k) clearance (K932533) under the regulatory framework for nerve conduction studies (regulation number 882.1550). It is classified as a Class II device and was determined to be substantially equivalent to a predicate device in 1994.
Are there different models or sizes available for the SmartScope?
The SmartScope appears to be available in multiple configurations, as indicated by the various registration numbers (e.g., 1067162, 8030229, etc.) and FEI numbers listed in the data. These likely correspond to different versions or accessories, but specific details on sizes or model variations would require consulting the manufacturer’s documentation or support.