← Back to catalogue
Innova Ct Option For Digital Fluoroscopic Imaging Systems Innova (4100 +4 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K052157
Identifiers
- 510(k) Number
- K052157 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Innova Ct Option For Digital Fluoroscopic Imaging Systems Innova (4100 +4 more) by GE Medical Systems, LLC — Class II — FDA_510K — listed in FDA 510(k) — 5…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K052157 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GE Medical Systems, LLC
Sources (1)
- FDA 510(k) K052157 24 fields · synced Jun 18, 2026