ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K090276 |
|---|---|
| Device Name | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | DQO · Cardiovascular |
| Decision Date | Feb 19, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1200 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The Siemens Acuson X300 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. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
Device Story
The Acuson X300 is a multi-purpose diagnostic ultrasound system. It processes acoustic signals received via various transducers (phased, convex, linear, intracardiac) to produce real-time 2D, M-mode, Doppler (pulsed, continuous, color, amplitude), and 3D/4D images. Used in clinical settings (radiology, cardiology, surgery) by trained healthcare professionals. The system includes analysis packages, such as the Arterial Health Package (AHP), which measures Intima Media Thickness (IMT) to assist in cardiovascular risk assessment. Output is displayed on the system monitor for physician interpretation to support clinical diagnosis and patient communication. Benefits include non-invasive visualization of internal structures and blood flow, aiding in the detection and management of various pathologies.
Clinical Evidence
Bench testing only. The system was verified and validated according to the company's design control process, including compliance with safety standards (UL 60601-1, IEC 60601-2-37, etc.) and acoustic output measurement standards (AIUM/NEMA UD-2, UD-3).
Technological Characteristics
Multi-purpose diagnostic ultrasound system. Supports various transducer types (phased, convex, linear, intracardiac). Features include Ensemble tissue harmonic imaging, 3D/4D imaging, SieScape panoramic imaging, SieClear spatial compounding, and Tissue Equalization Technology. Connectivity includes standard ultrasound interfaces. Complies with IEC 60601-1, IEC 60601-2-37, and ISO 10993-1 for biocompatibility.
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, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Includes measurement of anatomical structures and analysis packages for clinical diagnosis.
Regulatory Classification
Identification
An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.
Predicate Devices
- Siemens Acuson X300 (K080760)
- Siemens Acuson X300 (K071036)
- Siemens Acuson X300 (K061946)
- ACUSON CV70 Cardiovascular System (K050240)
- ACUSON Sequoia Ultrasound System (K063085)
- Arterial Health Package (AHP) software (K083149)
Related Devices
- K072676 — ACUSON X300 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Dec 18, 2007
- K090334 — ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medi Cal Solutions, Inc. · Feb 20, 2009
- K071036 — MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc., Ultrasound DI · May 16, 2007
- K061946 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Jul 21, 2006
- K080760 — ACUSON X300 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc., Ultrasound DI · Apr 25, 2008
Submission Summary (Full Text)
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690776
Siemens Medical Solutions USA, Inc. Ultrasound Division
ACUSON X300 ™ Diagnostic Ultrasound System 510(k) Submission
FEB 1 9 2009
# 510(k) Summary
Siemens Medical Solutions, Inc., Sponsor: Ultrasound Division 1230 Shorebird Way Mountain View, California 94043
Contact Person: Shelly Pearce Telephone: (650) 694-5988 Fax: (650) 694-5580
January 6, 2009 Submission Date:
ACUSON X300™ Diagnostic Ultrasound System Device Name: SONOVISTA X300 Diagnostic Ultrasound System ACUSON X300™ Diagnostic Ultrasound System, premium edition
#### Diagnostic Ultrasound System with Accessories Common Name:
# Classification:
Requlatory Class: 11 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 |
| Diagnostic Intravascular Catheter | FR # 870.1200 | Product Code 74-DQO |
# A. Legally Marketed Predicate Devices
The Siemens Acuson X300 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 X300 ultrasound system (K080760, K071036 and K061946) and the following:
- K050240, ACUSON CV70 Cardiovascular System .
- K063085, ACUSON Sequoia Ultrasound System �
- K071036, Acuson X300 Diagnostic Ultrasound System .
- K080760, ACUSON X300™ Diagnostic Ultrasound System, premiunm edition .
- K083149, Arterial Health Package (AHP) software ●
# B. Device Description:
The Acuson X300 has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment 미
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards I
- 8 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
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- B AJUM/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 1
- 93/42/EEC Medical Devices Directive E
- 1 Safety and EMC Requirements for Medical Equipment
- EN/IEC 60601-1 ■
- EN/IEC 60601-1-1 ■
- l EN/IEC 60601-1-2
- EN/IEC 60601-1-4 、『
- EN/IEC 60601-1-6 트
- 트 EN/IEC 60601-2-18
- 트 EN/IEC 60601-2-25
- IEC 1157 Declaration of Acoustic Power 동
- ISO 10993-1 Biocompatibility
# C. Intended Use
The Siemens Acuson X300 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.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
# 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 X300 modifications are verified and validated according to the company's design control process.
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Image /page/2/Picture/0 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" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
# DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siemens Medical Solutions USA, Inc., Ultrasound Group % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
FEB 19 2009
Re: K090276
Trade/Device Name: Acuson X300 Diagnostic Ultrasound Systems :
Regulation Number: 21 CFR 892.1560
Regulation Name: Ultrasonic pulsed echo imaging system
Regulatory Class: II
Product Code: IYO, IYN, and ITX
Dated: February 3, 2009
Received: February 4, 2009
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 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 missranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Acuson X300 Diagnostic Ultrasound Systems, as described in your premarket notification:
Transducer Model Number
P4-2 Phased Sector Array CH5-2 Convex Array VF10-5 Linear Array L9-5 Linear Array EC9-4 Convex Array EV9-4 Convex Array
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VF13-5 Linear Array P8-4 Phased Sector Array BE 9-4 Convex Array CW2 Continuous Wave CW5 Continuous Wave AcuNav 8F Intracardiac AcuNav 10F Intracardiac V5Ms TEE 4V1c Phased Sector Array VF13-5SP Linear Array C8-5 Tightly Curved Array 8L3 Linear "Regel" 10V4 Phased Array C7F2 Curved Array Mechanical 3D/4D EV9F4 Curved Array Mechanical 3D/4D L13F5 3D/4D Mechanical Wobbler Linear VF8-3 Linear Array P5-1 Phased Array C6-2 Convex Array SoundStar 10F P9-4 Phased 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 320); and ifrapplies ble, the electionic product radiation controll provisions (Sections 531-542 of the Prody 2F CFR 1000-1056.
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
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Enclosure(s)
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If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.
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Sincerely yours,
Joaquín M. Thaz
Janine M. Morris رق Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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# Indications for Use Statement
510(k) Number (if known): Ko90276
Device Name: Acuson X300 Diagnostic Ultrasound System
Indications For Use:
The Siemens Acuson X300 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.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
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 Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive. Abdominal and Radiological Devices 510(k) Number
X300 510(k) Submission
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### ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission
# Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
Intended Use:
ACUSON X300 Diagnostic Ultrasound Systems
ਾ | - | - |
・
.
ACUSON X300 Diagnostic Ultrasound Systems
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Specific<br>(Tracks1 & 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|-------------------------------------------------------|-------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal | Fetal | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-operative<br>(Note 6) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-operative<br>(Neuro)<br>Laparoscopic<br>Pediatric | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Neonatal Cephalic | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-rectal | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-vaginal | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Musculo-skel.<br>(Convent.) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Musculo-skel.<br>(Superfic) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-vascular | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Other<br>(Specify) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Cardiac Pediatric | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-vascular<br>(Cardiac) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-esophageal<br>(Cardiac) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Other (Specify) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Other (Specify) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| N = new indication; P = previously cleared by K080760 | | | | | | | | | | | |
| 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 | | | | | | | | | | |
| Note 8 | SieClear multi-view spatial compounding | | | | | | | | | | |
| Note 9 | Tissue Equalization Technology | | | | | | | | | | |
| Note 10 | Intracardiac imaging | | | | | | | | | | |
| Note 11 | Dynamic TCE | | | | | | | | | | |
| Note 12 | AHP | | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | | |
| Other<br>(Track1<br>Only) | Specific<br>(Tracks11& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | | P | P | P | P | P | P | | BMDC | Note<br>2,3,5,6,7,8,9,11 |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | SmallOrgan<br>(Note 1) | | | | | | | | | | |
| | Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | |
| | Musculo-skel.<br>(Convent) | | | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | |
| Cardiac | Cardiac Adult | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Cardiac Pediatric | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Other (Specify) | | | | | | | | | | |
Radiological Devices 510(k) Number Kogo23
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### Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
Intended Use:
P4-2 Phased Sector Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
Note 1 For example: breast, testes, thyrold, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3
3D imaging
B&W SiaScape panoramic imaging Note 4
Nota 5 Power SieScape panoramic Imaging
Nota 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Nota 8 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 9
Note 10 Intracardiac imaging
Nota 11 Dynamic TCE . :
borny In When (B) EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
:
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### Prescription Use (Per 21 CFR 801.109)
# Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
Intended Use:
CH5-2 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | | | |
|-------------------------------------------------------|-------------------------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------------|--|
| Other<br>( Track 1<br>Only) | Specific<br>(Tracks1 & 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | |
| | Fetal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Abdominal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Intra-operative<br>(Note 6) | | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | SmallOrgan<br>(Note 1) | | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | | |
| | Cardiac Adult | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| Cardiac | Cardiac Pediatric | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | |
| Peripheral<br>Vessel | Other (Specify)<br>Peripheral vessel | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Other (Specify) | | | | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | | | |
| Other<br>(Track 1<br>Only) | Specific<br>(Tracks1& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | |
| | Fetal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Abdominal | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Intra-operative<br>(Note 6) | | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | SmallOrgan<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Adult Cephalic | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Musculo-skel.<br>(Superfic) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Intra-vascular | | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | Note 12 | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11,12 | |
| | Other (Specify) | | | | | | | | | | | |
| N = new indication; P = previously cleared by K080760 | | | | | | | | | | | | |
| 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 SleScape panoramic imaging | | | | | | | | | | | |
| Note 6 | For example: abdominal, vascular | | | | | | | | | | | |
| Note 7 | Contrast agent imaging | | | | | | | | | | | |
| Note 8 | SieClear multi-view spatial compounding | | | | | | | | | | | |
| Note 9 | Tissue Equalization Technology | | | | | | | | | | | |
| Note 10 | Intracardiac Imaging | | | | | | | | | | | |
| Note 11 | Dynamic TCE | | | | | | | | | | | |
| Note 12 | AHP | | | | | | | | | | | |
eviously cleared by K080760
Note 1 For example: breast, testas, thyrold, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
Note 4 B&W SieScape panoramic Imaging
Note 5 Power SiaScape panoramic Imaging
Note 6 For example: abdominal, vascular Note 7
Contrast agent imaging
- Nota A SieClaar multi-view spatial compounding
- Note 9 Tissue Equalization Technology Note 10
- Intracardiac imaging. Note 11 . Dynamic TCE
(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 EHA/JJ MI. A 507 24
{9}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
ਕੂੰ ਦੇ '' '' '
510(k) Number (if known):
Device Name:
Intended Use:
VF10-5 Linear Array Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
{10}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
Intended Use:
L9-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
cended use.
Clinical Application Mode of Operation Other Color Specific ( Track 1 Color Amplitude Combinad A Other B ખ PWD CWD (Tracks11& 3) Velocity Only) Doppler Doppler (Specify) (Specify) Imagino Ophthalmic Ophthalmic Fetal Nota P P P P P BMDC 2,3,4,5,7,8,3,11 Abdominas " P . P P . · Note P ප BMDC 2,3,4,5,7,8,9,11 Intra-operative (Note 6) Intra-operative (Neuro) Laparoscopic Fatal Pediatric P P P Note P P BMDC 2,3,4,5,7,8,9,11 Imaging SmallOrgan P P P Note P & Other P BMDC (Note 1) 2,3,4,5,7,8,9,11 Neonatal Cephalic P P P Note P P BMDC 2,3,4,5,7,8,9,11 Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skal. P P P Note P P (Convent) BMDC 2,3,4,5,7,8,9,11 Musculo-skal. P P P Note P P BMDC (Superfic) 2,3,4,5,7,8,9,11 Intra-vascular Other (Specify) Cardiac Adult Cardlac Cardlac Pediatric Note 12 Intra-vascular (Carrisc) . . . The Paramation (1) and 201 .. ・・・・・・ Cartistics ... . .. Intra-Cardaio . .. Other (Specify) Peripheral Peripheral vessel P P P Note P P BMDC 2,3,4,5,7,8,9,11,12 Vassel Other (Specify)
N = new Indication; P = previously cleared by K080760
Note 1 For example: breast, testes, thyrold, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D Imaging
Note 4 B&W SieScape panoramic imaging
Nota 5 Power SieScape panoramic imaging
Nota 6 For example: abdominal, vascular Nota 7
Contrast agent imaging Note 8 SieClear multi-vlew spatial compounding
Nota 9 Tissue Equalization Technology
Nota 10 Intracardiac imaging
Note 11 Oynamic TCE
Note 12 AHP
> (PLEASE OO 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}
{11}------------------------------------------------
### ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission
### Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
Intended Use:
EC9-4 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|-----------------------------|-------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Other<br>(Track1<br>Only) | Specific<br>(Tracks1 & 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | | | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric<br>SmallOrgan<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-vaginal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | | | |
| | Musculo-skel<br>(Superfic) | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | |
| | Intra-Cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
N = new allocation, R = previously captured by Robo/CO
For example: breast, testes, thyrold, penis, prostate, etc Note 1
- Ensemble tissue harmonic imaging Note 2
- 3D imaging Note 3
B&W SieScape panoramic imaging Note 4
Power SleScape panoramic Imaging Note 5
For example: abdominal, vascular Note 6 Nota 7 Contrast agent imaging
Note 8 SleClear multi-view spatial compounding
- Note 9 Tissue Equalization Technology
Note 10 Intracardiac Imaging
Note 11 Dynamic TCE
> PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Acurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
{12}------------------------------------------------
### ACUSON X300m Diagnostic Ultrasound System 510{k) Submission
### Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known);
Device Name:
Intended Use:
EV9-4 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|-----------------------------|-------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|--|
| Other<br>( Track 1<br>Only) | Specific<br>(Tracks11& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | |
| | Fetal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Abdominal | | | | | | | | | | | |
| | Intra-operative<br>(Nota 6) | | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | | | | |
| | SmallOrgan<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Adult Cephalic | | | | | | | | | | | |
| | Trans-rectal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Trans-vaginal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Trans-urethral | | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | | |
| | Musculo-skel.<br>(Convent) | | | | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | | |
| | Intra-Cardiac | | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | |
reviously cleared by K080760
Note 1 For example: breast, testes, thyrold, penis, prostate, etc.
Ensemble tissue harmonic imaging Nota 2
3D imaging Note 3
B&W SleScape panoramic Imaging Note 4
Power SieScape panomic Imaging Note 5
Note 6
Note 7 Contrast agent imaging
Note 8 SleClear multi-view spatial compounding
Note 9 Tissue Equalization Technology Intracardiac imaging
Note 10 Note 11 Dynamic TCE
> (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)
{13}------------------------------------------------
### ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission
.47
### Diagnostic Ultrasound Indications for Use Form
香港
510(k) Number (if known):
### VF13-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
.. .. ...
Device Name: Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Other<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-operative<br>(Note 5) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | SmallOrgan<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Musculo-skel.<br>(Superfic) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-vascular | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | Note 12 |
| Cardiac | Cardiac Pediatric | | | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Other (Specify) | | | | | | | | | | |
Ensemble tissue harmonic imaging Note 2
Nota 3 3D imaging
Note 4 B&W SieScape panoramic imaging
- Nob 5 Power SieScape panoramic Imaging
- Nota 6 For example: abdominal, vascular
- Nota 7 Contrast agent imaging
- Nota 8 SieClear multi-view spatial compounding
Nota 9 Tissue Equalization Technology
- Note 10 Intracardiac Imaging
- Note 11 Dynamic TCE Note 12 AHP
-
(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)
{14}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
Intended Use:
P8-4 Phased Sector Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | | |
|-----------------------------|-------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Other<br>(Track1<br>Only) | Specific<br>(Tracks1& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,5,6,7,8,9,11 |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | SmallOrgan<br>(Note 1) | | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Musculo-skel.<br>(Superfic) | | | | | | |…
