ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K121646 |
|---|---|
| Device Name | ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Siemens Medical Solutions USA, Inc. Ultrasound Gro |
| Product Code | IYN · Radiology |
| Decision Date | Jun 22, 2012 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The Siemens Acuson X150 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular 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.
Device Story
ACUSON X150 is a mobile, software-controlled diagnostic ultrasound system. It acquires primary or secondary harmonic ultrasound echo data via various transducers (phased, convex, linear arrays). Data is processed and displayed on a flat panel display in multiple modes: B-Mode, Pulsed (PW) Doppler, Continuous (CW) Doppler, Color Doppler, Amplitude Doppler, harmonic imaging, and 3D imaging. The system provides on-screen thermal and mechanical indices for bio-effect monitoring. Operated by clinicians in clinical settings, the device facilitates anatomical measurements and analysis for clinical diagnosis. Output allows healthcare providers to visualize internal structures and blood flow, aiding in the diagnosis of various conditions across multiple medical specialties.
Clinical Evidence
Bench testing only. The device was evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety. It conforms to standards including UL 60601-1, IEC 60601-2-37, and AIUM/NEMA UD-2/UD-3.
Technological Characteristics
Mobile, software-controlled ultrasound system. Supports multiple transducer types (phased, convex, linear arrays). Connectivity includes flat panel display. Complies with IEC 60601-1, IEC 60601-2-37, and ISO 10993-1. Software-controlled signal processing for B-mode, Doppler, and harmonic imaging.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in general radiology, fetal, abdominal, intraoperative, pediatric, small parts, neonatal/adult cephalic, cardiac, transesophageal, pelvic, transcranial, OB/GYN, urology, vascular, and musculoskeletal applications.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- ACUSON X150 Diagnostic Ultrasound System (K081121)
- ACUSON SC2000 Diagnostic Ultrasound System (K113179)
- ZONARE z.one Ultra Ultrasound System (K101091)
- GE LOGIQ i, LOGIQ e, Vivid e (K113690)
- GE LogiqBooK XP (K014206)
- Sonosite M-turbo (K101757)
Related Devices
- K070576 — ACUSON X150 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Mar 26, 2007
- K081121 — MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc., Ultrasound DI · Jun 4, 2008
- K032111 — ACUSON CV70 CARDIOVASCULAR SYSTEM · Siemens Medical Solutions USA, Inc. · Jul 18, 2003
- K020353 — OMNIA X/XS ULTRASOUND SYSTEM · Siemens Medical Systems, Inc. · Feb 13, 2002
- K050240 — MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM · Siemens Medical Solutions USA, Inc. · Feb 15, 2005
Submission Summary (Full Text)
{0}------------------------------------------------
K121646
Siemens Medical Solutions USA, Inc. Ultrasound Division
ACUSON X150™ Diagnostic Ultrasound System Special 510(k) Submission
# SECTION 12 510(k) Summarv
JUN 2 2 2012
- 1. Sponsor: Siemens Medical Solutions USA, Inc., Ultrasound Division 685 East Middlefield Road Mountain View, California 94043
| 2. | Contact Person: | Shelly Pearce |
|----|-----------------|-------------------------------|
| | Title: | Regulatory Affairs Specialist |
| | Telephone: | (650) 694 5988 |
| | Fax: | (650) 694 5580 |
- 3. May 14, 2012 Submission Date:
- ACUSON X150™ Diagnostic Ultrasound System Device Name: 4. SONOVISTA X150 Diagnostic Ultrasound System (K081121)
- 5. Common Name: Diagnostic Ultrasound System with Accessories
| Classification:<br>6. | | | | | | | | | | |
|------------------------------------------|---------------|---------------------|--|--|--|--|--|--|--|--|
| Regulatory Class: | II | | | | | | | | | |
| Review Category: | Tier II | | | | | | | | | |
| Classification Panel: | Radiology | | | | | | | | | |
| Ultrasonic Pulsed Doppler Imaging System | FR # 892.1550 | Product Code 90-IYN | | | | | | | | |
| Ultrasonic Pulsed Echo Imaging System | FR # 892.1560 | Product Code 90-IYO | | | | | | | | |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX | | | | | | | | |
#### A. Legally Marketed Predicate Devices
The Siemens ACUSON X150 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number:
- . K081121, ACUSON X150™ Diagnostic Ultrasound System, SONOVISTA X150 Diagnostic Ultrasound System
- K113179, ACUSON SC2000™ Diagnostic Ultrasound System
- K101091, ZONARE z.one Ultra Ultra Ultrasoud System
- e K113690, GE LOGIQ i, LOGIQ e, Vivid e
- K014206, GE LogigBooK XP ●
- . K101757, Sonosite M-turbo
#### B. Device Description:
The Siemens ACUSON X150 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging on a Flat Panel Display.
{1}------------------------------------------------
#### C. Intended Use
The Siemens Acuson X150 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular 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.
#### D. Substantial Equivalence
The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.
#### E. Performance Data
The modifications to the Siemens ACUSON X150 Diagnostic Ultrasound System are verified and validated according to the company's design control process.
#### F. A brief discussion of nonclinical tests submitted, referenced, or relied on in
the 510(k) for a determination of substantial equivalence.
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:
UL 60601-1, Safety Requirements for Medical Equipment
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
93/42/EEC Medical Devices Directive
Safety and EMC Requirements for Medical Equipment
EN/IEC 60601-1
EN/IEC 60601-1-1
EN/IEC 60601-1-2
IEC 1157 Declaration of Acoustic Power
ISO 10993-1 Biocompatibility
Cleared patient contact materials, electrical and mechanical safety are unchanged.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, with three curved lines representing the staff and a single line representing the snake.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Medical Solutions USA, Inc. Ultrasound Group % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313
JUN 2 2 2012
Re: K121646 Trade/Device Name: ACUSON X150™ Diagnostic Ultrasound System SONOVISTA X150 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 4, 2012 Received: June 5, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amerodments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to I cacral controls provisions of the Act. The general controls provisions of the Act include the general of the our registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the ACUSON X150™ Diagnostic Ultrasound System, SONOVISTA X150 Diagnostic Ultrasound System, as described in your premarket notification:
# Transducer Model Number
P4-2 Phased Sector Array CH5-2 Convex Array VF10-5 Linear Array EC9-4 Convex Array Endocavity EV9-4 Convex Array
VF13-5 Linear Array P8-4 Phased Array L9-5 Linear Array P4-2 Litho Phased Sector Array
{3}------------------------------------------------
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de vice is olashired (800 a0070) regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I cacial states and states and submited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 6077, mooning (21 CFR Part 820); and if applicable, the electronic form in the qualify by occhine (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket I notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you dosite speerille ad resboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation emations the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Joshua Nipper at (301) 796-6524.
Sincerely Yours,
Michael D. O'Hare Esq.
Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
# SECTION 6 Indications for Use Forms
#### Indications for Use Statement
510(k) Number (if known):
ACUSON X150TM Diagnostic Ultrasound System Device Name: SONOVISTA X150 Diagnostic Ultrasound System
Indications For Use:
The Siemens Acuson X150 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Devices
510(k)K121646
Page 1 of
{5}------------------------------------------------
510(k) Number (if known):
#### ACUSON X150 Diagnostic Ultrasound System
Device Name: Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|----|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3 | | |
| Abdominal | | P | P | .P | P | P | P | | BMDC | Note 2,3 | | |
| Intraoperative<br>(Note 6) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3 | | |
| Small Organ<br>(Note 1) | | P | P | P | P | P | P | | BMDC | Note 2.3 | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 3 | | |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2 | | |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3 | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3 | | |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3 | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3 | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | .P | P | P | P | P | P | | BMDC | Note 2,3 | | |
| Musculo-skeletal<br>Superficial | | P | P | P | P | P | P | | BMDC | Note 2,3 | | |
| Other (specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by K070576; K081121 E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
3D imaging Note 3
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Devices
510(k) K121646
Page 2 of
{6}------------------------------------------------
510(k) Number (if known):
Device Name:
P4-2 Phased Sector Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3 | | |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3 | | |
| Intraoperative<br>(Note 6) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3 | | |
| Small Organ<br>(Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3 | | |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3 | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by K070576; K081121 E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
- 3D imaging Note 3
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Contrast agent imaging Note 7
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Devices
510(k) K121646
Page 3 of
{7}------------------------------------------------
## Siemens Medical Solutions USA, Inc. Ultrasound Division
#### Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
. CH5-2 Convex Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K070576; K081121 E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
3D imaqinq Note 3
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Arhuel D'H
Division Sign-Off
Office of In Vitro Diagnostic Devices
510(k)K121646
Page 4 of
{8}------------------------------------------------
#### 510(k) Number (if known):
Device Name:
VF10-5 Linear Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows: ﺮ
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2.3 |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K070576; K081121 E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Contrast agent imaging Note 7
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Devices
510(k) K121646
Page 5 of
{9}------------------------------------------------
510(k) Number (if known):
Device Name:
EC9-4 Convex Array Endocavity Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3 | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(Note 6) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Note 1) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3 | |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by K070576; K081121 E = added under Appendix E
For example: breast; testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Contrast agent imaging Note 7
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign Office of In Vitro Diagnostic Devices
510(k) K121646
Page 6 of
{10}------------------------------------------------
#### 510(k) Number (if known):
Device Name:
EV9-4 Convex Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K070576; K081121 E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
3D imaging Note 3
Note 4 B&W SieScape panoramic imaging
Note 5 · Power SieScape panoramic imaging
Note 6 For example: abdominai, vascular
Note 7 Contrast agent imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Devices
510(k) K121646
{11}------------------------------------------------
510(k) Number (if known):
Device Name:
VF13-5 Linear Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K070576; K081121 E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Note .5 Power SieScape panoramic imaging
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Michael D. O'Hern
Division Sign-Off Office of In Vitro Diag
510(k) K121646.
Page 8 of
{12}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
P8-4 Phase Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K070576; K081121 E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
3D imaging Note 3
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Devices
510(k) K121646
Page 9 of
{13}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
L9-5 Linear Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K070576; K081121 E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Contrast agent imaging Note 7
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
h D Ohm
Division Sign Officer
on Sign-Off Office of In Vitro Diagnostic Devices
510(k) K121646
Page 10 of
{14}------------------------------------------------
510(k) Number (if known):
Device Name:
# P4-2 Litho Phased Sector Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2.3 |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K070576, K081211
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Contrast agent imaging Note 7
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Office of In Vitro Diagnostic Devices
510(k)K121646
Page 11 of
