ORTHOPACS— 510(k) K033825
Substantially EquivalentEtrauma.Com Corp.
FDA 510(k) clearance K033825 for ORTHOPACS, Substantially Equivalent on 2004-02-02. Applicant: Etrauma.Com Corp.. Device class: 2.
Clearance details
- Applicant
- Etrauma.Com Corp.
- 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
- Hopkonton, MA, US
Recent devices under product code LLZ
view allMore clearances from Etrauma.Com Corp.
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 K033825
K-number listed on FDA's recall record- Z-2159-2016 — Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
- Z-2144-2016 — Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
- Z-2531-2016 — iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
- Z-2532-2016 — iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033825.
Data sourced from openFDA. This site is unofficial and independent of the FDA.