Dynacad/Prostate Interventional (Dynaloc/Prostate)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133030 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dynacad/Prostate Interventional (Dynaloc/Prostate) is a computer-based image-guidance accessory classified under System, Image Processing, Radiological. It functions as an adjunct to commercially available Magnetic Resonance (MR) imaging systems, providing real-time patient data processing, visualization, and storage capabilities for interventional procedures.
This device is designed for use in radiology settings and supports image analysis, display, and recording of simulated tracked insertions. Supplied as a software application, it is intended for single-use or multi-use depending on institutional protocols, with no explicit sterility requirements stated. The system is MRI-safe and operates under FDA 510(k) clearance (K133030) and MDD compliance, adhering to regulatory standards for radiological image processing systems.
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: Dynacad/Prostate Interventional (Dynaloc/Prostate) (K133030) — Fda 510 ..., DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)… - FDA.report, Dynacad/Prostate Interventional (Dynaloc/Prostate) (K133030) — Fda 510 ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K133030 | Class II | Active |
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Manufacturer
- Manufacturer
- Invivo Corporation
Sources (2)
- FDA 510(k) K133030 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026