# K123622: Acuson

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Dec 5, 2012 after 12 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K935595 (1995). 143 ancestors in all.
96 later devices descend from it; 4 cite it directly.
0 of 240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113179: Acuson SC2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2011) Summary page 1.
- K111674: Acuson, Siemens Medical Solutions USA, Inc. (2011) Summary page 1.
- K121699: Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2012) Summary page 1.
- K072365: Sequoia Plus Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2007) Summary page 3.
- K102017: SC2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2010) Summary page 3.

## Most influential descendants
- K132804: Acuson S1000 / S2000 / S3000 (2013), 73 descendants of its own
- K140959: Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems (2014), 60 descendants of its own
- K142876: ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems (2014), 58 descendants of its own
- K152369: ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System (2015), 54 descendants of its own
- K130754: Acuson SC2000 Diagnostic Ultrasound System (2013), 54 descendants of its own

## Recalls of this device
- Nov 7, 2016 · Class II · Z-0667-2017: Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.
- Apr 8, 2016 · Class II · Z-1592-2016: While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor
- Oct 7, 2015 · Class II · Z-0182-2016: Siemens will provide all customers a new version of system software (VA35E or VB10C depending on the hardware configuration). Hardware fixes will be implemented to address situations where the metal c
- Aug 19, 2015 · Class II · Z-2783-2015: The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. If these differences a
- Jan 12, 2015 · Class II · Z-1056-2015: The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position.
- Apr 23, 2014 · Class II · Z-1667-2014: Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly display the color flow data in the wrong position and when Doppler Frequency is adjusted, the system do
- Apr 23, 2014 · Class II · Z-1668-2014: Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could cause the need for the study to be r
- Dec 22, 2013 · Class II · Z-0824-2014: The user interface assembly on the ACUSON SC2000 may become loose with the potential for the entire module to fall off of the ultrasound system.
- Dec 22, 2013 · Class II · Z-0825-2014: The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel, making it unable to steer or control during tr
- Jul 10, 2013 · Class II · Z-0052-2014: Software issue results in inaccurate 3D image may result in ablation in wrong location.
- Mar 28, 2013 · Class II · Z-1081-2013: When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hardware contai
- Jul 11, 2012 · Class II · Z-1584-2015: In certain situations, loss of post exercise images can occur in Stress Echo.
- May 11, 2012 · Class II · Z-1581-2015: In some cases, the system is unable to capture a clip or image during a routine scan.

## Indications for use
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal lntraoperative, lntraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC20OO Ultrasound System are: Cardiac Imaging Applications and Analysis The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the headt, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the headt of adult and pediatric patients. The system transmits ultrasound energy from either a transthoracic or transesophageal approach in adult and pediatric patients; and from a transthoracic approach. in neonatal and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Vascular Imaging Applications and Analysis The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck: superficial and deep veins and arteries in the arms and legs; and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Superficial Imaging Applications The system transmits ultrasound energy into various padts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. lntraoperative Imaging Applications The system transmits ultrasound energy into various parts of the body of adult patients creating 20 (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during neurological intraoperative procedures. Transcranial Imaging Applications The system transmits ultrasound energy into the cranium of adult patients creating 20 (6), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Source page: https://510kreport.com/device/K123622
Methodology: https://510kreport.com/methodology