KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM— 510(k) K023772
Substantially EquivalentAcuson Corp.
FDA 510(k) clearance K023772 for KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM, Substantially Equivalent on 2002-11-22. Applicant: Acuson Corp.. Device class: 2.
Clearance details
- Applicant
- Acuson 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
- Mountainview, CA, US
Recent devices under product code LLZ
view allMore clearances from Acuson 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 K023772
K-number listed on FDA's recall record- Z-1601-2016 — Syngo Dynamics; Kinetdx Picture Archiving and Communications System
- Z-0826-2016 — software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images.
- Z-1183-2016 — Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading of mammography images.
- Z-1613-2014 — Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
- Z-1216-2014 — syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023772.
Data sourced from openFDA. This site is unofficial and independent of the FDA.