ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K121699 |
|---|---|
| Device Name | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Jun 22, 2012 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence, Pediatric, 3rd-Party Reviewed |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K121699 · Jun 22, 2012 | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | Peer-reviewed clinical literature containing normative data for Intima Media Thickness | The device uses published normative tables to provide physicians with reference data for Intima Media Thickness measurements, aiding in the communication of cardiovascular risk to patients. | Arterial Health Package; Intima Media Thickness; Normative tables; Cardiovascular risk |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk; Peer-reviewed clinical literature / Consensus statement | Patients undergoing carotid ultrasound for subclinical vascular disease assessment | Not applicable for this study | Normative values for Intima Media Thickness |
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".
Device Story
Multi-purpose mobile diagnostic ultrasound system; acquires harmonic ultrasound echo data; displays in B-Mode, Pulsed (PW) Doppler, Continuous (CW) Doppler, Color Doppler, Amplitude Doppler, Harmonic Imaging, 3D/4D imaging. Operated by clinicians in clinical settings. Provides anatomical measurements and analysis packages (e.g., Arterial Health Package for Intima Media Thickness). Output displayed on flat panel; assists physicians in clinical diagnosis and patient communication regarding cardiovascular health. Benefits include non-invasive assessment of anatomical structures and vascular health.
Clinical Evidence
Bench testing only. Evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety. Conforms to UL 60601-1, IEC 60601-2-37, AIUM/NEMA UD-2/UD-3, and ISO 10993-1 standards.
Technological Characteristics
Mobile, software-controlled ultrasound system. Supports various transducers (phased, convex, linear, TEE, intracardiac). Modes: B, M, PW/CW Doppler, Color/Amplitude Doppler, 3D/4D. Connectivity: Flat panel display. Safety: Thermal/mechanical indices display. Standards: IEC 60601-1, IEC 60601-2-37, ISO 10993-1.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body 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.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- ACUSON X300 Diagnostic Ultrasound System (K090276, K093531)
- ACUSON SC2000 Diagnostic Ultrasound System (K113179)
- ZONARE z.one Ultra Ultrasound System (K101091)
- GE LOGIQ i, LOGIQ e, Vivid e (K113690)
- GE LogiqBooK XP (K014206)
- Sonosite M-turbo (K101757)
Submission Summary (Full Text)
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ACUSON X300™ Diagnostic Ultrasound System Special 510(k) Submission
# SECTION 12 510(k) Summary
JUN 2 2 2012
- 11.1. Sponsor: Siemens Medical Solutions USA, Inc., Ultrasound Division 685 East Middlefield Road Mountain View, California 94043
11.2. Contact Person: Shelly Pearce Title: Regulatory Affairs Specialist (650) 694 5988 Telephone: (650) 694 5580 Fax:
11.3. Submission Date: May 15, 2012
- 11.4. Device Name: ACUSON X300™ Diagnostic Ultrasound System SONOVISTA X300 Diagnostic Ultrasound System ACUSON X300 ™ Diagnostic Ultrasound System, premium edition (K090276, K093531)
#### 11:5. Common Name: Diagnostic Ultrasound System with Accessories
11.6. Classification: Regulatory Class: ll Review Category: Tier II Radiology Classification Panel:
| 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-DQC |
A. Legally Marketed Predicate Devices
The Siemens ACUSON X300 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number:
- K090276. K093531. ACUSON X300™ Diagnostic Ultrasound System, SONOVISTA . X300 Diagnostic Ultrasound System, ACUSON X300™ Diagnostic Ultrasound System, premium edition
- K113179, ACUSON SC2000™ Diagnostic Ultrasound System .
- K101091, ZONARE z.one Ultra Ultrasoud System .
- K113690, GE LOGIQ i, LOGIQ e, Vivid e .
- K014206, GE LogiqBooK XP .
- . K101757, Sonosite M-turbo
### B. Device Description:
The Siemens ACUSON X300 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical
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indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppier Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
#### 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 modifications to the Siemens ACUSON X300 Diagnostic Ultrasound System are verified and validated according to the company's design control process.
F. A brief discussion of nonclinical tests submitted, referenced, or relied on in
the 510(k) for a determination of substantial equivalence.
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:
UL 60601-1, Safety Requirements for Medical Equipment
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
93/42/EEC Medical Devices Directive
Safety and EMC Requirements for Medical Equipment
EN/IEC 60601-1
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EN/IEC 60601-1-1
EN/IEC 60601-1-2
IEC 1157 Declaration of Acoustic Power
ISO 10993-1 Biocompatibility
Cleared patient contact materials, electrical and mechanical safety are unchanged.
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three abstract human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line, creating a sense of unity and movement.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
JUN 2 2 2012
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
Re: K121699
K121077
Trade/Device Name: ACUSON X300™ Diagnostic Ultrasound System; SONOVISTA X 300 Diagnostic Ultrasound Systems; ACUSON X300™ Diagnostic Ultrasound System, premium edition
Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and DQO Dated: June 7, 2012 Received: June 8, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave leviewed your beenou broke is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the enclosure) to regally mankelou production Device Amendments, or to devices that have been May 26, 1970, the Chacement and of the Federal Food, Drug, and Cosmetic Act (Act). You reclassified in accordance with the provisions to the general controls provisions of the Act. The general may, therefore, thanket the device, basyon is month registration, listing of devices, good Controls provisions of the beling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with This determination of Salostantial System, SONOVISTA X 300 Diagnostic Ultrasound the ACUSON X 300 - Diagnostic Ultrasound System, premium edition, 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 VF13-5 Linear Array P8-4 Phased Sector Array
BE 9-4 Convex Array CW2 Continuous Wave Doppler CW5 Continuous Wave Doppler AcuNav 8F Intracardiac AcuNav 10F Intracardiac V5Ms TEE 4V1c Phased Sector Array VF13-5SP Linear Array
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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 Subled of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any I DA has made a deceminations administered by other Federal agencies. You must comply with all the I cocrar statutes and regulations as annot limited to: registration and listing (21 CFR Part 807); labeling (21 Act 3 requirements, morable wing 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. This 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 go to 11 you desire specific advice for your er offices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Intip://www.ida.gov/Abouti Drivellers/Office of Compliance. Also, please note the regulation Devices and Radiological reallir o (SEPT Part 807.97). For questions regarding the reporting of referents in promote the MDR regulation (21 CFR Part 803), please go to regarding the reporting of daverse overse w/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Joshua Nipper at (301) 796-6524.
Sincerely Yours,
Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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## SECTION 6 Indications for Use Forms
### Indications for Use Statement
510(k) Number (if known):
Device Name:
ACUSON X300TM Diagnostic Ultrasound System SONOVISTA X300 Diagnostic Ultrasound System ACUSON X300™ Diagnostic Ultrasound System, premium edition
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 In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Devices
510(k)K121699
Page 1 of
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510(k) Number (if known):
Device Name: Intended Use:
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>(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 | 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) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Laparoscopic | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| 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) | 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 Adult | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Cardiac | 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 |
| | Intra-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 | Peripheral vessel | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Vessel | 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; K090276
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 3 3D imaging
3D imaging
Power SieScape panoramic imaging Note 5
Tissue Equalization Technology Note 9
Dynamic TCE Note 11
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 2
Note 4
Note 6
Note 8
Note 10
Ensemble tissue harmonic imaging
B&W SieScape panoramic imaging
For example: abdominal, vascular
Intracardiac imaging
SieClear multi-view spatial compounding
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office of In Vitro Diagnostic Devices
K121699
Page 2 of
Contrast agent imaging Note 7
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### ACUSON X300™ Diagnostic Ultrasound System Special 510(k) Submission
#### 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:
| 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 | 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 Adult | | P | P | P | P | P | P | | BMDC | Note<br>2.3.4.5.7.8,9.11 |
| Cardiac | 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 | Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Vessel | Other (Specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K080760
| Note 1 | For example: breast, testes, thyroid, penis, prostate, etc. |
|--------|-------------------------------------------------------------|
|--------|-------------------------------------------------------------|
- Note 3 3D imaging
Power SieScape panoramic imaging Note 5 Contrast agent imaging Note 7
- Tissue Equalization Technology Note 9
- Note 11 Dynamic TCE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 2 Note 4
Note 6
Note 8
Note 10
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office/of In Vitro Diagnostic Devices
KlAl699
Page 3 of
Ensemble tissue harmonic imaging
B&W SieScape panoramic imaging
For example: abdominal, vascular
Intracardiac imaging
{8}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
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:
Intended Use:
Clinical Application Mode of Operation Color Other Color Amplitude Cambined Other Specific PWD CWD B M Velocity ( Track1 A Doppler Doppler (Specify) (Specify) (Tracks11& 3) Imaging Only) Ophthalmic Ophthalmic Note P P BMDC P P P Fetal 2.3.4.5.7,8.9.11 Note BMDC P P P P P Abdominal 2,3,4,5,7,8,9,11 Intra-operative (Note G) Intra-operative (Neuro) Laparoscopic Note P BMDC P P P P Pediatric Fetal 2,3,4,5,7,8,9,11 SmallOrgan Imaging & Other (Note 1) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Note Musculo-skel. P P P P P BMDC 2.3.4.5.7.8.9.11 . (Convent.) Musculo-skel. (Superfic) Intra-vascular Qther (Specify) Note P P BMDC P P P Cardiac Adult 2,3.4,5,7,8,9,11 Note P p P P BMDC P Cardiac Cardiac Pediatric 2,3,4,5,7,8,9,11 Intra-vascular (Carliac) Trans-esophageal (Cardiac) Intra-cardiac Other (Specify) Note P BMDC P P P Peripheral vessel P . 2,3,4,5,7,8,9,11 Peripheral Vessel Other (Specify)
N = new indication; P = previously cleared by K080760
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- Note 3 3D imaging
- Note 5 Power SieScape panoramic imaging
- Note 7 Contrast agent imaging
- Tissue Equalization Technology Note 9
Note 11 Dynamic TCE
(FLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K121699
Page 4 of
- Note 4 Note 6
Note 2
- For example: abdominal, vascular
- SieClear multi-view spatial compounding Note 8
- Note 10 Intracardiac imaging
Ensemble tissue harmonic imaging B&W SieScape panoramic imaging
{9}------------------------------------------------
510(k) Number (if known):
Device Name:
VF10-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
Intended Use:
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 | | 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 | Pediatric | | 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 | | 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-rectai | | | | | | | | | | |
| | 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-skei.<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 | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral | Peripheral vessel | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9.11 |
| Vessel | Other (Specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K080760
- For example: breast, testes, thyroid, penis, prostate, etc. Note 2 Note 1
- 3D imaaina Note 3
- Power SieScape panoramic imaging Note 5
- Contrast agent imaging Note 7
- Tissue Equalization Technology Note 9
- Note 11 Dynamic TCE
(FLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Note 4
Note 6
Note 8
Note 10
Division Sign-Off - Office of In-Vitro Diagnostic Devices
Kla1699
510(k)
Page 5 of
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B&W SieScape panoramic imaging
For example: abdominal, vascular
Intracardiac imaging
{10}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
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:
Intended Use:
Clinical Application Mode of Operation Other Color Specific Color Amplitude Combined Other A B M PWD CWD Velocity ( Track 1 (Tracks11& 3) Doppler Doppler (Specify) (Specify) Only) Imaging Ophthalmic Ophthalmic Note P P P P P BMDC Fetal 2,3,4,5,7,8,9,11 Note P P P P P BMDC Abdominal 2,3,4,5,7,8,9,11 Intra-operative (Note 6) Intra-operative (Neuro) Laparoscopic Note P P P BMDC Fetal Pediatric P P 2.3.4.5.7.8.9,11 · SmallOrgan Imaging Note P P P P P BMOC 2,3,4,5,7,8,9,11 & Other (Note 1) Note P Neonatal Cephalic P P P p BMDC 2,3,4,5,7,8,9,11 Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. Note P P P P P BMDC 2,3,4,5,7,8,9,11 (Convent.) Musculo-skel. Note P P P P BMDC P 2,3,4,5,7,8,9,11 (Superfic) Intra-vascular Other (Specify) Cardiac Adult Cardiac Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-Cardaic · Other (Specify) Note P P P BMDC Peripheral vessel P P Peripheral 2.3.4.5.7.8.9.11
Other (Specify) N = new indication; P = previously cleared by K080760
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- 3D imaging Note 3
- Power SieScape panoramic imaging Note 5 Contrast agent imaging
Note 7
Vessel
Tissue Equalization Technology Note 9 Dynamic TCE Note 11
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 2
Note 4
Note 6
Note 8
Note 10
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K121699
Ensemble tissue harmonic imaging
B&W SieScape panoramic imaging
For example: abdominal, vascular
Intracardiac imaging
{11}------------------------------------------------
### ACUSON X300™ Diagnostic Ultrasound System Special 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:
Diagnostic imaging or fluid flow analysis o
| Clinical Application | Mode of Operation | | | | | | | | | | |
|---------------------------|-------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Other<br>(Track1<br>Only) | Specific<br>(Tracks 11& 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 | | | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal | Pediatric | | | | | | | | | | |
| Imaging<br>& Other | 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 | Peripheral vessel | | | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K080760
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- 3D imaging Note 3
- Power SieScape panoramic imaging Note 5
- Note 7 Contrast agent imaging
- Tissue Equalization Technology Note 9
- Note 11 Dynamic TCE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 2
Note 4
Note G
Note 8
Nota 10
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K121699
Page 7 of
Ensemble tissue harmonic imaging
B&W SieScape panoramic imaging
For example: abdominal, vascular
Intracardiac imaging
{12}------------------------------------------------
510(k) Number (if known):
Device Name:
EV9-4 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
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>(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>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal | Pediatric | | | | | | | | | | |
| Imaging<br>& Other | 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 | Peripheral vessel | | | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K080760
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- 3D imaging Note 3
- Power SieScape panoramic imaging Note 5
- Contrast agent imaging
Tissue Equalization Technology Note 7
- Note 9
- Dynamic TCE Note 11
- (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
oncurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Note 2
Note 4
Note 6
Note 8
Note 10
Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K121699
Page 8 of
Ensemble tissue hamonic imaging
B&W SieScape panoramic imaging
For example: abdominal, vascular
Intracardiac imaging
{13}------------------------------------------------
510(k) Number (if known):
Device Name:
VF13-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
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>(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) | | | 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 | | | | | | | | | | | |
| 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 | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Other (Specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by K080760
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- Note 3 3D imaging
- Power SieScape panoramic imaging Note 5
- Contrast agent imaging Note 7
Tissue Equalization Technology Note 9
- Dynamic TCE Note 11
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Note 2
Note 4
Note 6
Note 8
Note 10
Ensemble tissue harmonic imaging
B&W SieScape panoramic imaging
For example: abdominal, vascular
Intracardiac imaging
Division Sign-Off - Office of in Vitro Diagnostic Devices
510(k) K121699
{14}------------------------------------------------
510(k) Number (if known):
Device Name:
P8-4 Phased Sector Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
Intended Use:
Other
( Track 1
Only) Ophthalmic
Diagnostic imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation Calor Specific Color Amplitude Combined Other CWD Velocity B M PWD A (Specify) (Tracks11& 3) Doppler Doppler (Specify) Imaging 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 | Pediatric | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Imaging<br>& Other | 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 | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent) | P | 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 | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Cardiac | 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 | Peripheral vessel | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Vessel | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared by K080760
| Note 1 | For example: breast, testes, thyroid, penis, prostate, etc |
|--------|------------------------------------------------------------|
|--------|------------------------------------------------------------|
- Note 3 3D imaging
- Power SieScape panoramic imaging Note 5
Contrast agent imaging Note 7 Tissue Equalization Technology Note 9
- Dynamic TCE Note 11
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 2
Note 4
Note 6
Note 8
Note 10
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K121699
Page 10 of _
Ensemble tissue harmonic imaging
B&W SieScape panoramic imaging
SieClear multi-view spatial compounding
For example: abdominal, vascular
{15}------------------------------------------------
510(k) Number (if known):
BE 9-4 Convex 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>(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 2,3,4,5,7,8,9 |
| | Abdominal | | | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal | Pediatric | | | | | | | | | | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| | Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| | Trans-vaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| | 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 | Peripheral vessel | | | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | | | |
| | N = new indication; P = previously cleared by K080760 | | | | | | | | | | |
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- 3D imaging Note 3
- Power SieScape panoramic imaging Note 5
Note 7 Contrast agent imaging
Tissue Equalization Technology Note 9
- Note 11 Dynamic TCE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 2
Note 4
Note 6
Note 8
Note 10
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Olagnostic Devices
510(k) K121699
Page 11 of
Ensemble tissue harmonic imaging
B&W SieScape panoramic imaging
For example: abdominal, vascular
Intracardiac imaging
{16}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
CW2 Continuous Wave Doppler Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
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>(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 | | | | | |
| | Abdominal | | | | | P | | | | | |
| | Intra-operative<br>(Note 6) | | | | | P | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal | Pediatric | | | | | P | | | | | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | | | | | P | | | | | |
| | Neonatal Cephalic | | | | | P | | | | | |
| | Adult Cephalic | | | | | P | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | P | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | |
| | Cardiac Adult | | | | | P | | | | | |
| Cardiac | Cardiac Pediatric | | | | | P | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Perpheral | Peripheral vessel | | | | | P | | | | | |
| Vessel | Other (Specify) | | | | | | | |…
