ViewPoint 6— 510(k) K241300
Substantially EquivalentGe Healthcare GmbH
FDA 510(k) clearance K241300 for ViewPoint 6, Substantially Equivalent on 2024-07-02. Applicant: Ge Healthcare GmbH. Device class: 2.
Clearance details
- Applicant
- Ge Healthcare GmbH
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- München, DE
Recent devices under product code LLZ
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K241300
K-number listed on FDA's recall record- Z-0935-2026 — GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
- Z-3146-2024 — ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K241300.
Data sourced from openFDA. This site is unofficial and independent of the FDA.