(26 days)
The Siemens Acuson X150 ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculosketal, Great Vessel, 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.
Diagnostic imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intraoperative (abdominal, vascular), Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
The Siemens Acuson X150 has been designed to meet the following product safety 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, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment; AIUM/NEMA UD-2, 1998 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.
The Siemens Acuson X150 Ultrasound System is a diagnostic ultrasound system with accessories. The provided text, a 510(k) summary, indicates that the device's performance was verified and validated according to the company's design control process, asserting substantial equivalence to its predicate device, the Siemens Sonoline G40 ultrasound system. However, specific acceptance criteria and detailed clinical study results (like sensitivity, specificity, or accuracy) are not provided in the document.
The document primarily focuses on establishing substantial equivalence based on intended use and technological characteristics, and lists compliance with various safety and performance standards. It also details the clinical applications and modes of operation for the main system and individual transducers, indicating whether these are "new indications" (N) or "previously cleared by FDA" (P).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy thresholds) are mentioned in this 510(k) summary. The "reported device performance" is implicitly that the device performs equivalently to the predicate device and meets established safety and performance standards.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative performance metrics (e.g., sensitivity, specificity, accuracy). | "Verifited and validated according to the company's design control process." |
| Substantial equivalence to predicate device (Siemens Sonoline G40 ultrasound system) regarding intended use and technological characteristics. | Device found substantially equivalent by FDA. |
| Compliance with various safety and performance standards (UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2, IEC 1157, ISO 10993-1). | Device is designed to meet these standards. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not mention any specific sample sizes (number of patients or images) used for testing the device's clinical performance. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention any details about experts used to establish ground truth, nor their number or qualifications.
4. Adjudication Method
The document does not mention any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention an MRMC comparative effectiveness study, nor does it provide any effect size for human readers improving with or without AI assistance. The device in question is an ultrasound system, not an AI-assisted diagnostic tool as understood in the typical context of MRMC studies for AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not mention a standalone study. The device is an ultrasound system, which inherently involves human operation.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for any performance evaluation.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size.
9. How the Ground Truth for the Training Set Was Established
The document does not mention a training set or how its ground truth might have been established.
Summary of Device Performance Study as Described in the 510(k) Summary:
The Siemens Acuson X150 Ultrasound System underwent verification and validation according to the company's design control process to demonstrate "substantial equivalence" to its predicate device, the Siemens Sonoline G40 ultrasound system. This substantial equivalence was affirmed by the FDA based on the device's intended use, technological characteristics, and compliance with a comprehensive list of recognized safety and performance standards (e.g., UL 60601-1, IEC 60601-2-37, AIUM/NEMA standards). The submission did not include specific clinical performance data (like sensitivity, specificity, or accuracy) derived from studies involving test sets, expert adjudication, or MRMC studies, as is often seen in submissions for AI/CADe devices. Instead, the focus was on technical and safety compliance and demonstrating that the device functions similarly to a legally marketed predicate.
{0}------------------------------------------------
SECTION 11
510(k) Summary Prepared February 22, 2007
MAR 2 6 2007
| Sponsor: | Siemens Medical Solutions USA, Inc.,Ultrasound Division1230 Shorebird WayP.O. Box 7393Mountain View, California 94039-7393 |
|---|---|
| ---------- | -------------------------------------------------------------------------------------------------------------------------------------------- |
| Contact Person: | Sheila W. Pickering | |||||
|---|---|---|---|---|---|---|
| Telephone: | (650) 943 7187 | |||||
| Fax: | (650) 943 7053 |
- Submission Date: February 16, 2007
Device Name: Acuson X150 Ultrasound System
Common Name: Diagnostic Ultrasound System with Accessories
Classification:
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 Ultrasound system is substantially equivalent to the Siemens Sonoline G40 ultrasound system.
B. Device Description:
The Siemens Acuson X150 has been designed to meet the following product safety standards:
- 이 UL 60601-1, Safety Requirements for Medical Equipment
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- 이 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive
- 를 Safety and EMC Requirements for Medical Equipment
- 에 EN/IEC 60601-1
- EN/IEC 60601-1-1
- 마 EN/IEC 60601-1-2
- 트 IEC 1157 Declaration of Acoustic Power
- 트 ISO 10993-1 Biocompatibility
{1}------------------------------------------------
Siemens Acuson X150 5 10(k) Notification CONFIDENTIAL
C. Intended Use
The Siemens Acuson X150 ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculosketal, Great Vessel, 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 X150 modifications are verified and validated according to the company's design control process.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sheila W. Pickering, Ph.D. Senior Director of Regulatory Affaris Siemens Medical Solutions USA, Inc. Ultrasound Division 1230 Shorebird Way, P.O. Box 7393 MOUNTAIN VIEW CA 94039-7393
MAR 2 6 2007
Re: K070576
Trade Name: Acuson X150 Ultrasound Imaging System Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: IYN Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: IYO Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Regulatory Class: II Dated: February 22, 2007 Received: February 28, 2007
Dear Dr. Pickering:
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 Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Numbers P4-2 CH5-2 VF10-5 EC9-4 EV9-4 VF13-5 P8-4 1 0-5
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Page 2 - Dr. Sheila Pickering
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 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 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 Ewa Czerska. M.D. at (240) 276-3666,
Sincerely yours,
Daniel le Lyman
N
DE
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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SECTION 7
Intended Use of the Device
510(k) Number (if known):
Device Name: Acuson X150 Ultrasound Imaging System
Indications For Use:
The Siemens Acuson X150 ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, 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.
David A. Seaymon
Division Sign-Off Division of Reproductive, Abdomina and Radiological Devices
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use __ (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
ACUSON X150 Diagnostic Ultrasound System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N | BMDC | Note 2,3 | ||
| Abdominal | N | N | N | N | N | N | BMDC | Note 2,3 | ||
| Intraoperative(Note 6) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | N | N | N | N | N | N | BMDC | Note 2,3 | ||
| Small Organ(Note 1) | N | N | N | N | N | N | BMDC | Note 2,3 | ||
| Neonatal Cephalic | N | N | N | N | N | N | BMDC | Note 3 | ||
| Adult Cephalic | N | N | N | N | N | N | BMDC | Note 2 | ||
| Cardiac | N | N | N | N | N | N | BMDC | Note 2,3 | ||
| Transesophageal | ||||||||||
| Transrectal | N | N | N | N | N | N | BMDC | Note 2,3 | ||
| Transvaginal | N | N | N | N | N | N | BMDC | Note 2,3 | ||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | N | N | N | N | N | N | BMDC | Note 2,3 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | N | N | N | N | N | N | BMDC | Note 2,3 | ||
| Musculo-skeletalSuperficial | N | N | N | N | N | N | BMDC | Note 2,3 | ||
| Other (specify) |
N = new indication; P = previously cleared by FDA; 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
Daniel h. Larson
(Division Sign Division of Reproductive. and Radiological Devic 510(k) Nu
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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Diagnostic Ultrasound Indications for Use Form
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:
| Clinical Application | Mode of Operation | Other(Specify) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(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(Note 6) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2,3 | ||
| Small Organ(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-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; 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
- Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
David A. Wagner
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070
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Concurrence of CDRH, Office of Device Evaluation (ODE)
{7}------------------------------------------------
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:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | BMDC | Note 2,3 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3 | |||
| Intraoperative (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3 | |||
| Small Organ (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 Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; 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
- Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Doinh h. Sagnon
(Division Sign-Off)
Division of Reproductive, Ab and Radiological Device 510(k) Numbe
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{8}------------------------------------------------
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3 | |||
| Intraoperative(Note 6) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3 | |||
| Small Organ(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-skeletalConventional | P | P | P | P | P | BMDC | Note 2,3 | |||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMDC | Note 2,3 | |||
| Other (specify) |
N = new indication; P = previously cleared by FDA; 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
Note 7 Contrast agent imaging
David he. Sigman
(Division Sign-Off)
Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
(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)
Page 17 of 51
{9}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
Intended Use:
EC9-4 Convex Array Endocavity 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 Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | |
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | BMDC | Note 2,3 | ||||
| Abdominal | |||||||||||
| Intraoperative (Note 6) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (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 Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- 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: abdominal, vascular
- Note 7 Contrast agent imaging
David R. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
(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)
Page 18 of 51
{10}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
Intended Use:
EV9-4 Convex 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 Color Clinical Application Color Amplitude Combined Other B PWD CWD A M Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic P P P P P BMDC Note 2,3 Fetal Abdominal Intraoperative (Note 6) Intraoperative Neurological Pediatric Small Organ (Note 1) Neonatal Cephalic Adult Cephalic Cardiac Transesophageal P Transrectal P P P P BMDC Note 2,3 P P P P P BMDC Transvaginal Note 2,3 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
- Ensemble tissue harmonic imaging Note 2
- 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
David R. Ingram
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number
,但
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Concurrence of CDRH, Office of Device Evaluation (ODE)
{11}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
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 Color Clinical Application Amplitude Color Combined Other B M PWD CWD Velocity A Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal Abdominal Intraoperative (Note 6) Intraoperative Neurological p P Pediatric b P P BMDC Note 2,3 P P P Small Organ P b BMDC Note 2,3 (Note 1) P P BMDC Neonatal Cephalic b b b Note 2,3 Adult Cephalic Cardiac Transesophageal Transrectal Transvaginal Transurethral Intravascular P P P Peripheral vessel P P BMDC Note 2,3 Laparoscopic P P Musculo-skeletal P P P BMDC Note 2,3 Conventional Musculo-skeletal P P P P P BMDC Note 2,3 Superficial Other (specify)
N = new indication; P = previously cleared by FDA; 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
- B&W SieScape panoramic imaging Note 4
- Power SieScape panoramic imaging Note 5
- For example: abdominal, vascular Note 6
- Contrast agent imaging Note 7
David R. Hysom
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number
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Concurrence of CDRH, Office of Device Evaluation (ODE)
{12}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
P8-4 Phase Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as
Intended Use:
follows: Mode of Operation Color Clinical Application Color Amplitude Combined Other B PWD CWD A M Velocity Doppler Doppler (Specify) (Specify) Imaging
| Ophthalmic | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Fetal | P | P | P | P | P | P | BMDC | Note 2,3 | |
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3 | |
| Intraoperative(Note 6) | |||||||||
| IntraoperativeNeurological | |||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2,3 | |
| Small Organ(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-skeletalConventional | |||||||||
| Musculo-skeletalSuperficial | |||||||||
| 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
3D imaging Note 3
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Contrast agent imaging Note 7
Daniel R. Syverson
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
{13}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
L9-5 Linear 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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3 | ||||
| Intraoperative(Note 6) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3 | ||||
| Small Organ(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-skeletalConventional | P | P | P | P | P | BMDC | Note 2,3 | ||||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMDC | Note 2,3 | ||||
| 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
David h. Logem
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.