MULTIX FUSION— 510(k) K121513

Clearance details

Applicant

Siemens Medical Solution

Product code

Code KPR

Device class

Class 2

Regulation

21 CFR 892.1680

Advisory panel

Radiology

Date received

2012-05-21

Decision date

2012-08-10

Decision

Substantially Equivalent

Clearance type

Special

Location

Mavern, PA, US

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• K260488 — MULTIX Impact; MULTIX Impact C2026-08-31
• K260481 — GC85A2026-08-27
• K260482 — DRE Duo2026-06-15
• K253446 — AeroDR TX c022026-04-10

• K121138 — ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM2012-05-17
• K061449 — SYNGO EXPERT-12006-07-25
• K050199 — MAGNETOM SYMPHONY A TIM SYSTEM2005-02-18

Other

6

Total

6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0297-2019 — Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Integrated (model number 10746667) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Wireless (model number 10893300) with Tube stand 3D V (model number 7042042)Class II·Terminated·Siemens Medical Solutions USA, Inc·20180803
• Z-0013-2017 — Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)applications.Class II·Terminated·Siemens Medical Solutions USA, Inc·20160801
• Z-0014-2017 — Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including:skull, chest, abdomen and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)applications.Class II·Terminated·Siemens Medical Solutions USA, Inc·20160801
• Z-1505-2014 — MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.Class II·Terminated·Siemens Medical Solutions USA, Inc·20140213

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121513.