Innova 2121iq, Innova 3131iq, Innova 4100, Innova 4100iq, Innova 3100, Innova 3…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K061163 FDA 510(k)
- FDA Product Code
- OWB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1650 FDA 510(k)
- Regulation Number
- 892.1650 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Innova series comprises interventional fluoroscopic X-ray systems designed for real-time imaging during cardiovascular and peripheral vascular procedures. These devices provide high-resolution fluoroscopy, digital subtraction angiography, and optional intravascular ultrasound (IVUS) imaging to support diagnostic and therapeutic interventions in radiology settings.
These systems are intended for use in clinical environments where precise imaging is required, such as catheterization labs and angiography suites. Supplied as reusable medical devices, they are regulated under FDA 510(k) clearance (K061163) and classified as Class II devices. The Innova 2100IQ with IVUS Opt includes an integrated intravascular ultrasound option, while other models vary in fluoroscopic field size and imaging capabilities. Sterilization and maintenance protocols are manufacturer-specified for reuse.
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: Innova 2121iq, Innova 3131iq, Innova 4100, Innova 4100iq, Innova 3100 ..., PDF K061163 - Innova 2121iq, Innova 3131iq, Innova 4100, Innova 4100iq ..., Innova 2121iq, Innova 3131iq, Innova 4100, Innova 4100iq, Innova 3100 ..., GE Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova… - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061163 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
Sources (1)
- FDA 510(k) K061163 24 fields · synced Oct 6, 2026