DR SYSTEMS PACS, RELEASE 6.1— 510(k) K041935
Substantially EquivalentDr Systems, Inc.
FDA 510(k) clearance K041935 for DR SYSTEMS PACS, RELEASE 6.1, Substantially Equivalent on 2004-08-16. Applicant: Dr Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Dr Systems, Inc.
- 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
- San Diego, CA, US
Recent devices under product code LLZ
view allMore clearances from Dr Systems, Inc.
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 K041935
K-number listed on FDA's recall record- Z-3105-2017 — Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems
- Z-2566-2018 — Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
- Z-1385-2017 — DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
- Z-1426-2017 — DR Systems Unity PACS software, now known as Merge Unity PACS
- Z-0939-2017 — DR Systems Unity PACS software, now known as Merge Unity PACS software.
- Z-2551-2016 — Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041935.
Data sourced from openFDA. This site is unofficial and independent of the FDA.