MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM
Device Facts
| Record ID | K081121 |
|---|---|
| Device Name | MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM |
| Applicant | Siemens Medical Solutions USA, Inc., Ultrasound DI |
| Product Code | IYO · Radiology |
| Decision Date | Jun 4, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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.
Device Story
ACUSON X150 is a multi-purpose diagnostic ultrasound system. It utilizes various transducers (phased, convex, linear arrays) to acquire acoustic signals from the human body. The system processes these signals to generate real-time 2D, M-mode, Doppler (PWD, CWD, Color, Amplitude), and 3D images. It includes analysis packages for anatomical measurements and fluid flow assessment. Used in clinical settings (radiology, cardiology, OB/GYN, etc.) by trained healthcare professionals. Output is displayed on the system monitor for clinical diagnosis. Benefits include non-invasive visualization of internal structures and hemodynamics to support clinical decision-making.
Clinical Evidence
Bench testing only. The device modifications were verified and validated according to the company's design control process. No clinical data was required for this submission.
Technological Characteristics
Diagnostic ultrasound system supporting B, M, PWD, CWD, Color Doppler, Amplitude Doppler, and 3D imaging modes. Complies with UL 60601-1, IEC 60601-2-37, AIUM/NEMA UD-2/UD-3, ISO 10993-1 (biocompatibility), and ISO 14971 (risk management). Transducers include phased, convex, and linear arrays. Software-based analysis packages for anatomical measurements.
Indications for Use
Indicated for diagnostic ultrasound imaging and 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. Prescription use only.
Regulatory Classification
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- Siemens ACUSON X150 ultrasound system (K070576)
Submission Summary (Full Text)
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K08//121
USON X150™ Ultrasound System Special 510(k) Submission
Product Code 90-ITX
JUN - 4 2008
Siemens Medical Solutions USA, Inc. Ultrasound Division CONFIDENTIAL
#### SECTION 12
#### 510(k) Summary
Siemens Medical Solutions USA, Inc., Sponsor: Business Unit Ultrasound 1230 Shorebird Way Mountain View, California 94043 Contact Person: Martina Vogt Telephone: (425) 557 1434 (425) 391 9198 Fax: April 18, 2008 Submission Date: ACUSON X150TM Diagnostic Ultrasound System Device Name: SONOVISTA X150 Diagnostic Ultrasound System Common Name: Diagnostic Ultrasound System with Accessories Classification: II Regulatory Class: 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
#### A. Legally Marketed Predicate Devices
Diagnostic Ultrasound Transducer
The Siemens ACUSON X150 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens ACUSON X150 ultrasound system (K070576).
FR # 892.1570
#### B, Device Description:
The Siemens ACUSON X150 has been designed to meet the following product safety standards:
- I UL 60601-1, Safety Requirements for Medical Equipment
- I IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment 트
- ど AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 트 ANJM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 트 93/42/EEC Medical Devices Directive
- I Safety and EMC Requirements for Medical Equipment
- I EN/IEC 60601 - 1
- 트 EN/EC 60601-1-1
- l EN/IEC 60601-1-2
- 동 EN/IEC 60601-1-4
- EN/IEC 60601-1-6
- 피 EN/IEC 60601-2-18
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- 트 EN/EC 60601-2-25
- 미 IEC 61157 Declaration of Acoustic Power
- 트 ISO 10993-1 Biocompatibility
- 트 ISO 14971 Risk Management
#### 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.
### 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 ACUSON X150 modifications are verified and validated according to the company's design control process.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# JUN - 4 2008
Ms. Martina Vogt Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. Ultrasound Division 1230 Shorebird Way MOUNTAIN VIEW CA 94043
Re: K081121
Trade/Device Name: ACUSON 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: April 18, 2008 Received: April 21, 2008
Dear Ms. Vogt:
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 Amendments, 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 the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual 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, 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
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# VF13-5 Linear Array P8-4 Phased Array L9-5 Linear Array P4-2 Litho Phased Sector Array
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain
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other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Sundar Rajan at (240) 276-3666.
Sincerely yours,
Jozpu M. Whay
ਿੰਗ Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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ACUSON X150"M Ultrasound System Special 510(k) Submission
# Indications for Use
510(k) Number (if known):
Device Name: ACUSON 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 X (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 Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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510(k) Number (if known):
Device Name: Intended Use:
# ACUSON X150 Diagnostic Ultrasound System
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; 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
Note 4 B&W SieScape panoramic imaging
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 Device Evaluation (ODE) |
| | 6 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 |
Why
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices 1081121
510(k) Nu
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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; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
3D imaging Note 3
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
ision of Reproductive, Abdominal and
adiological Devices
510(k) Number K08112/
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CH5-2 Convex Array Transducer for use with:
510(k) Number (if known):
Device Name:
Intended Use:
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 | | 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; 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
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
(PLEASE DO NOT WRITE BELOW
Conc
| (Division Sign-Off) | |
|---------------------|-----------------------------------------|
| | Division of Reproductive, Abdominal and |
OW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) currence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
| 510(k) Number | R1101 |
|---------------|-------|
|---------------|-------|
Radiological Devices
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Siemens Medical Solutions USA, Inc. Ultrasound Division CONFIDENTIAL
# Diagnostic Ultrasound Indications for Use Form
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:
| | 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; 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
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
tony M. Why
(Division Sign Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081121
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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; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
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 Device Evaluation (ODE)
Concur
Sign-Off
Prescription Use (Per 21 CFR 801.109)
(Division Sign-On)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K08/12/
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Siemens Medical Solutions USA, Inc. Ultrasound Division CONFIDENTIAL
# Diagnostic Ultrasound Indications for Use Form
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; 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
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
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 Device Evaluation (ODE) | |
| Prescription Use (Per 21 CFR 801 109) | |
Division of Reproductive, Abdominal Radiological Device 510(k) Number
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510(k) Number (if known):
Device Name:
Intended Use:
VF13-5 Linear 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 | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| 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 2,3 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| 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; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081121
{13}------------------------------------------------
510(k) Number (if known):
Device Name:
P8-4 Phase 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 | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Adult Cephalic | | | | | | | | | | |
| 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; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081121
{14}------------------------------------------------
510(k) Number (if known):
Device Name:
# L9-5 Lincar Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems
Intended Use:
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; 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
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
{15}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
P4-2 Litho Phased Sector 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 Color Color Amplitude Combined Other B A M PWD CWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal N N N N N N BMDC Note 2,3 Abdominal N N N N N BMDC N Note 2,3 Intraoperative (Note 6) Intraoperative Neurological Pediatric N N N N N N BMDC Note 2,3 Small Organ (Note 1) Neonatal Cephalic Adult Cephalic N N N N ત્વ N BMDC Note 2,3 Cardiac Note 2,3 N N N ત ત્વ N BMDC Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify)
N = new indication; P = previously cleared by FDA; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Amor herta
A FASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) encurrence of CDRH, Office of Device Evaluation (ODE)
Division of Reproductive, Abdominal an Radiological Devices 5(U(k) Number
Prescription Use (Per 21 CFR 801.109)
Section 6
