ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM— 510(k) K123001
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K123001 for ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2012-10-26. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Moutain View, CA, US
Recent devices under product code IYN
view all- K261585 — Diagnostic Ultrasound System (Nuewa A20W) +10 more
- K261617 — Diagnostic Ultrasound System (11+ models)
- K263150 — V10 Diagnostic Ultrasound System +10 more
- K261933 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
More clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
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 K123001
K-number listed on FDA's recall record- Z-1572-2016 — ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
- Z-1504-2014 — Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123001.
Data sourced from openFDA. This site is unofficial and independent of the FDA.