Identifiers
- 510(k) Number
- K120884 FDA 510(k)
- FDA Product Code
- DPT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2120 FDA 510(k)
- Regulation Number
- 870.2120 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pericam Psi is an extravascular blood-flow probe designed for real-time perfusion imaging. It utilizes laser speckle contrast imaging to measure blood perfusion in tissue at the microcirculation level.
This device is a Class 2 cardiovascular system that has received FDA 510(k) clearance. It is intended for use in clinical and research settings as a non-contact and noninvasive imaging solution.
Frequently asked questions
What is the primary function of the Pericam Psi?
The Pericam Psi is an extravascular blood-flow probe designed to provide real-time perfusion imaging. It utilizes laser speckle contrast imaging technology to measure blood perfusion within tissue at the microcirculation level.
Is the Pericam Psi an invasive device?
No, the Pericam Psi is a non-contact and noninvasive imaging solution. It is designed to measure perfusion without requiring physical penetration of the tissue, making it suitable for both clinical and research environments.
What is the regulatory status of the Pericam Psi?
The Pericam Psi is a Class 2 cardiovascular device that has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices under the cardiovascular medical specialty.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PeriCam PSI - Perimed, PeriCam PSI HR - Perimed, K120884 FDA 510 (k) - PERICAM PSI | Perimed AB, PDF PeriCam PSI System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120884 | Class II | Active |
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Manufacturer
- Manufacturer
- Perimed AB
Sources (1)
- FDA 510(k) K120884 24 fields · synced Sep 22, 2026