SIENET TELERADIOLOGY PRODUCT LINE— 510(k) K955394
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K955394 for SIENET TELERADIOLOGY PRODUCT LINE, Substantially Equivalent on 1996-02-21. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code LMC
- Device class
- Class 2
- Regulation
- 21 CFR 892.2040
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Iselin, NJ, US
Recent devices under product code LMC
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allRecalls naming K955394
K-number listed on FDA's recall record- Z-1354-2015 — Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.
- Z-1027-2015 — Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K955394.
Data sourced from openFDA. This site is unofficial and independent of the FDA.