Merge PACS— 510(k) K173475
Substantially EquivalentMerge Healthcare Incorporated
FDA 510(k) clearance K173475 for Merge PACS, Substantially Equivalent on 2017-12-08. Applicant: Merge Healthcare Incorporated. Device class: 2.
Clearance details
- Applicant
- Merge Healthcare Incorporated
- 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
- Hartland, WI, US
Recent devices under product code LLZ
view allMore clearances from Merge Healthcare Incorporated
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 K173475
K-number listed on FDA's recall record- Z-2062-2019 — Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
- Z-2063-2019 — Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173475.
Data sourced from openFDA. This site is unofficial and independent of the FDA.