MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM
Device Facts
| Record ID | K071036 |
|---|---|
| Device Name | MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM |
| Applicant | Siemens Medical Solutions USA, Inc., Ultrasound DI |
| Product Code | IYN · Radiology |
| Decision Date | May 16, 2007 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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.
Device Story
ACUSON X300 is a multi-purpose diagnostic ultrasound system; utilizes various transducers (phased, convex, linear, intracardiac, TEE) to acquire acoustic signals from human body; system processes signals to generate real-time diagnostic images and fluid flow analysis; used in clinical settings (radiology, cardiology, etc.) by trained healthcare professionals; output displayed on system monitor for clinical assessment; aids in diagnosis and monitoring of various anatomical structures and physiological conditions; benefits include non-invasive visualization and hemodynamic assessment.
Clinical Evidence
Bench testing only. The device modifications were verified and validated according to the company's design control process. No clinical data was required for this 510(k) submission.
Technological Characteristics
Multi-purpose diagnostic ultrasound system; supports various transducer types (phased, convex, linear, TEE, intracardiac); complies with UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-2/UD-3, and ISO 10993-1 biocompatibility standards. Features include tissue harmonic imaging, 3D/4D imaging, panoramic imaging (SieScape), spatial compounding (SieClear), and tissue equalization technology.
Indications for Use
Indicated for diagnostic 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, and peripheral vascular applications. Prescription use only.
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
- Siemens Acuson X300 ultrasound system (K061946)
Related Devices
- K093531 — ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medi Cal Solutions, Inc. · Dec 1, 2009
- K072676 — ACUSON X300 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Dec 18, 2007
- K080760 — ACUSON X300 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc., Ultrasound DI · Apr 25, 2008
- K081121 — MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc., Ultrasound DI · Jun 4, 2008
- K090276 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Feb 19, 2009
Submission Summary (Full Text)
{0}------------------------------------------------
### SECTION 11
#### 510(k) Summary
| Sponsor: | Siemens Medical Solutions USA, Inc.,<br>Ultrasound Division<br>1230 Shorebird Way<br>Mountain View, California 94043 | MAY 16 2007 |
|------------------|----------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Martina Vogt | |
| Telephone: | (425) 557 1434 | |
| Fax: | (425) 391 9198 | |
| Submission Date: | April 11, 2007 | |
| Device Name: | ACUSON X300™ Diagnostic Ultrasound System<br>SONOVISTA X300 Diagnostic 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 |
| 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 (K061946).
#### B. Device Description:
The Siemens Acuson X300 has been designed to meet the following product safety standards:
- 트 UL 60601-1, Safety Requirements for Medical Equipment
- 트 IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- 트 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- 트 AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 프 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- . 93/42/EEC Medical Devices Directive
- 바 Safety and EMC Requirements for Medical Equipment
- EN/EC 60601-1
- EN/IEC 60601-1-1
- 트 EN/IEC 60601-1-2
{1}------------------------------------------------
- 유 IEC 61157 Declaration of Acoustic Power
- 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.
#### 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.
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Martina Vogt Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 1230 Shorebird Way MOUNTAIN VIEW CA 94043
MAY 16 2007
Re: K071036
Trade Name: ACUSON X300 Diagnostic Ultrasound Systems Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX and DQO Dated: April 11, 2007 Received: April 16, 2007
Dear Ms. Vogt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the ACUSON 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 VF13-5 Linear Array P8-4 Phased Array BE9-4 Convex Array CW2 Continuous Wave Doppler CW5 Continuous Wave Doppler Acu Nav 8F Intracardiac
Acu Nav 10F Intracardiac V5Ms TEE 4V1c Phased Array VF13-5SP Linear Array C8-5 Tight Curved Array 8L3 Linear "Regel" 10V4 Phased Array Neonatal High Frequency C7F2 Curved Array Mechanical 3D/4D EV9F4 Curved Array Mechanical 3D/4D L13F5 3D/4D Mechanical Wobbler Linear VF8-3 Linear
{3}------------------------------------------------
## Page 2 - Ms. Martina Vogt
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified (dos are controls. Existing major regulations affecting your device It may be subject to sach as 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 I Tease be advised that I DTT official of our device complies with other requirements of the Act that I Drinas Intatutes and regulations administered by other Federal agencies. You must of any I coural statutes and regerments, including, but not limited to: registration and listing (21 comply with an the 10th 3 requirements, More, and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping I ms device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested information, merculing acounts of the Center's September 30, 1997 "Information for Manufacturers In Appendix U, (encrosou) of the Senter tic Ultrasound Systems and Transducers." If the special Secking Manching Cloudins unaceptable values (e.g., acoustic output greater than approved report is incomplete or comains anaooopation faract (organisation units which as a result may be considered adulterated or misbranded.
The special report should réference the manufacturer's 510(k) number. It should be clearly and The special report should be submitted in designitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket This letter will anow you to begin marketing your device to a legally marketed notification. The I Driving of succion 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 If you dosire specific advision at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Oremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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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Page 3 – Ms. Martina Vogt
If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon
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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510(k) Number (if known):
ACUSON X300 Diagnostic Ultrasound Systems
Device Name:
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Intraoperative<br>(Note 6) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Intraoperative<br>Neurological | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Small Organ<br>(Note 1) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transesophageal | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9 |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transurethral | | | | | | | | | | |
| Intravascular | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Musculo-skeletal<br>Superficial | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Other (specify) | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 |
N = new indication; P = previously cleared by FDA (K061946); E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
For example: abdominal, vascular Note 6
Note 7 , Contrast agent imaging
SieClear multi-view spatial compounding Note 8
Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | <img alt="signature" src="signature.png"/> Nancy C Brogdon |
|-----------------------------------------------------------|---------------------------------------------------------------|
| Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) | Division of Reproductive, Abdominal, and Radiological Devices |
| 510(k) Number | K071036 |
Pg. 6.2 of 6.25Diagnostic Ultrasound Indications for Use Form
Pg. 6.2 of 6.25
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510(k) Number (if known):
Device Name:
## P4-2 Phased Sector Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,5,6,7,8,9 |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K061946); E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Noțe 2 Ensemble tissue harmonic imaging
3D imaqing Note 3
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
SieClear multi-view spatial compounding Note 8
Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071036
Diagnostic Ultrasound Indications for Use Form
Pg. 6.3 of
{7}------------------------------------------------
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:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K061946); 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
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Note 8 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 9
Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAC Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071036
{8}------------------------------------------------
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:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Small Organ<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 | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K061946); 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
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
SieClear multi-view spatial compounding Note 8
Tissue Equalization Technology Note 9
Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF N Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broydon
Prescription Use (Per 21 CFR 801.109)
D
(Division Sign-Oft)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071036
Diagnostic Ultrasound Indications for Use Form
Pg. 6.5 of 6.25
{9}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
#### L9-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2.3.4.5.7.8.9 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Small Organ<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 | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K061946); 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
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
- Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
SieClear multi-view spatial compounding Note 8
Tissue Equalization Technology Note 9
Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071036
g. 6.6 of 6.25
{10}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
#### EC9-4 Convex Array Endocavity Transducer for use with: ACUSON X300 Diagnostic Uitrasound 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 Velocity A M Doppler Doppler (Specify) (Specify) Imaging Ophthalmic P P P P P BMDC Note 2,3,4,5,7,8,9 Fetal Abdominal Intraoperative (Note 6) Intraoperative Neurological Pediatric Small Organ P P P P P BMDC Note 2,3,4,5,7,8,9 (Note 1) P P Neonatal Cephalic P P P BMDC Note 2,3,4,5,7,8,9 Adult Cephalic Cardiac Transesophageal P P BMDC Note 2,3,4,5,7,8,9 Transrectal P P P Transvaginal P P P P P BMDC Note 2,3,4,5,7,8,9 Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify)
N = new indication; P = previously cleared by FDA (K061946); 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
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Contrast agent imaging Note 7
SieClear multi-view spatial compounding Note 8
Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF N Concurrence of CDRH, Office of Device Evaluation (ODE)
DE)
Nancy Broadon
Prescription Use (Per 21 CFR 801.109)
(Division Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Diagnostic Ultrasound Indications for Use Form
Pg. 6.7 of 6.25
{11}------------------------------------------------
510(k) Number (if known):
Device Name:
#### 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:
Intended Use:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative<br>(Note 6) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ<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 | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K061946); E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Contrast agent imaging Note 7
SieClear multi-view spatial compounding Note 8
Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy brogdon
ictive. Abdominal, and 510(k) Num
Section 6
Diagnostic Ultrasound Indications for Use Form
Pg. 6.8 of 6.25
{12}------------------------------------------------
510(k) Number (if known): .
Device Name:
Intended Use:
#### VF13-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| | | | | | | | Mode of Operation | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2.3.4.5.7.8.9 | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | |
| Intraoperative<br>(Note 6) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | |
| Small Organ<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 | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K061946); E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Contrast agent imaging Note 7
SieClear multi-view spatial compounding Note 8
Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
| Division Sign Off) | |
BrogdonPrescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071036
{13}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
# P8-4 Phase Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,45,7,8,9 |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K061946); 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
- Power SieScape panoramic imaging Note 5
- For example: abdominal, vascular Note 6
- Note 7 Contrast agent imaging
- Note 8 SieClear multi-view spatial compounding
- Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
|--------------------------------------------------------|--|
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071036
Diagnostic Ultrasound Indications for Use Form
Pg. 6.10 of 6.25
{14}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
#### BE9-4 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(Note 6) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<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 | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K061946); 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
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
(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)
Nancy C. Hogdon
(Division Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Section 6
{15}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
#### CW2 Continuous Wave Doppler 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 | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | P | | | | | |
| Abdominal | | | | | P | | | | | |
| Intraoperative<br>(Note 6) | | | | | P | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ<br>(Note 1) | | | | | P | | | | | |
| Neonatal Cephalic | | | | | P | | | | | |
| Adult Cephalic | | | | | P | | | | | |
| Cardiac | | | | | P | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | P | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K061946); 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
Contrast agent imaging Note 7
Note 8 SieClear multi-view spatial compounding
Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C Brogdon
(Division S Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Section 6
Diagnostic Ultrasound Indications for Use Form
Pg. 6.12 of 6.25
{16}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
#### CW5Continuous Wave Doppler Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | P | | | | | |
| Abdominal | | | | | P | | | | | |
| Intraoperative<br>(Note 6) | | | | | P | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ<br>(Note 1) | | | | | P | | | | | |
| Neonatal Cephalic | | | | | P | | | | | |
| Adult Cephalic | | | | | P | | | | | |
| Cardiac | | | | | P | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | P | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K061946); 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
- B&W SieScape panoramic imaging Note 4
- Note 5 Power SieScape panoramic imaging
- For example: abdominal, vascular Note 6
- Note 7 Contrast agent imaging
- SieClear multi-view spatial compounding Note 8
- Tissue Equalization Technology Note 9
- Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
|--------------------------------------------------------|--|
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number
K071036
V an
Diagnostic Ultrasound Indications for Use Form
Pg. 6.13 of 6.25
{17}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
#### Acu Nav 8F Intracardiac 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 of the human body as follows.
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | P | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional<br>Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (Intra-cardiac) | P | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 |
N = new indication; P = previously cleared by FDA (K061946); 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
Note 6 For example: abdominal, vascular
Contrast agent imaging Note 7
Note 8 SieClear multi-view spatial compounding
Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Muat |
|--------------------------------------------------------|------|
|--------------------------------------------------------|------|
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071036
{18}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
#### Acu Nav 10F Intracardiac Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | |…
