LogoFDA 510(k) Search
K Number
K061946
Device Name
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC.
Date Cleared
2006-07-21

(11 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic imaging or fluid flow analysis of the human body as follows: General Radiology, Fetal, Abdominal, Intracperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Device Description
The Siemens Acuson X300 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a FPD(Flat Panel Display) display.
More Information

K050034, K052894, K043016, K042044

Not Found

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.

No
The device is described as a "diagnostic ultrasound system" used for "diagnostic imaging or fluid flow analysis" and "clinical diagnosis purposes," which indicates its use for diagnosis rather than treatment.

Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "analysis packages that provide information that is used for clinical diagnosis purposes." Additionally, the "Device Description" identifies it as a "diagnostic ultrasound system."

No

The device description explicitly states it is a "software-controlled, diagnostic ultrasound system" and describes its function as acquiring ultrasound echo data and displaying it. This indicates the device includes hardware components (the ultrasound system itself) in addition to the software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) in vitro (outside the body).
  • This device is a diagnostic ultrasound system used for in vivo (within the body) imaging and analysis of the human body. The intended use and device description clearly state its function is to acquire and display ultrasound data from within the body for diagnostic purposes.

The information provided describes a medical imaging device, not a device that performs tests on biological samples outside the body.

N/A

Intended Use / Indications for Use

The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intracperative, 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.

Diagnostic imaging or fluid flow analysis of the human body as follows:

ACUSON X300 Diagnostic Ultrasound Systems:

Clinical ApplicationABMPWDCWDColor DopplerAmplitude DopplerColor Velocity ImagingCombined (Specify)Other (Specify)
FetalNNNNNNNBMDCNote 2,3,4,5,7,8,9
AbdominalNNNNNNNBMDCNote 2,3,4,5,7,8,9
Intraoperative (Note 6)NNNNNNNBMDCNote 2,3,4,5,7,8,9
Intraoperative NeurologicalNNNNNNNBMDCNote 2,3,4,5,7,8,9
PediatricNNNNNNNBMDCNote 2,3,4,5,7,8,9
Small Organ (Note 1)NNNNNNNBMDCNote 2,3,4,5,7,8,9
Neonatal CephalicNNNNNNNBMDCNote 2,3,4,5,7,8,9
Adult CephalicNNNNNNNBMDCNote 2,3,4,5,7,8,9
CardiacNNNNNNNBMDCNote 2,3,4,5,7,8,9
TransesophagealNNNNNNNBMDCNote 2,3,7,8,9
TransrectalNNNNNNNBMDCNote 2,3,4,5,7,8,9
TransvaginalNNNNNNNBMDCNote 2,3,4,5,7,8,9
IntravascularNNNNNNNBMDCNote 2,3,7,8,9,10
Peripheral vesselNNNNNNNBMDCNote 2,3,4,5,7,8,9
Musculo-skeletal ConventionalNNNNNNNBMDCNote 2,3,4,5,7,8,9
Musculo-skeletal SuperficialNNNNNNNBMDCNote 2,3,4,5,7,8,9
Other (specify)NNNNNNNBMDCNote 2,3,7,8,9,10

Product codes

IYN, IYO, ITX

Device Description

The Siemens Acuson X300 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a FPD(Flat Panel Display) display.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Intraoperative, Pediatric, Small Organ (e.g., breast, testes, thyroid, penis, prostate), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Intravascular, Peripheral vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

Indicated Patient Age Range

Neonatal, Pediatric, Adult

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K050034, K052894, K043016, K042044

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

0

Siemens Acuson X300 Diagnostic Ultrasound Syste 510(k) Submission

510(K) SUMMARY

JUL 21 2006

Siemens Acuson X300 Diagnostic Ultrasound system

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

1. Submitted By:

Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird Way Mountain View, California 94043

Contact Person: Sheila W. Pickering Requiatory Affairs Phone (650) 943 7187 Fax (6500 943 7053

Date Prepared: June 16, 2006

2. Proprietary Names:

Siemens Acuson X300™ Diagnostic Ultrasound System Sonoline Premier Plus Diagnostic Ultrasound System Sonavista X 300 Diagnostic Ultrasound System

Common/ Usual Name:

Diagnostic Ultrasound System with Accessories

Classification Name:

21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System Ultrasonic Pulsed Echo Imaging System Diagnostic Ultrasound Transducer

FR # 892.1550 FR # 892 1560 FR # 892.1570 Product Code 90-IYN Product Code 90-IYO Product Code 90-1TX

3. Predicate Device:

  • K050034, Antares Diagnostic Ultrasound System .
  • K052894, Sonoline G60 S Diagnostic Ultrasound System .
  • K043016, Sonoline Orchid Diagnostic Ultrasound System ●
  • . K042044, Acuson CV70 Cardiovascular System

Device Description: 4.

The Siemens Acuson X300 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a FPD(Flat Panel Display) display.

The Siemens Acuson X300, has been designed to meet the following product safety standards:

  • 파 UL 60601-1, Safety Requirements for Medical Equipment
  • 트 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
  • AIUM/NEMA, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment

1

  • AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound l
  • 이 93/42/EEC Medical Devices Directive
  • I Safety and EMC Requirements for Medical Equipment
    • I EN 60601-1
    • . EN 60601-1-1
    • I EN 60601-1-2
  • . IEC 61157 Declaration of Acoustic Power
  • l ISO 10993 Biocompatibility

5. Intended Uses:

The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intracperative, 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.

6. Technological Comparison to Predicate Device:

The Siemens Acuson X300 is substantially equivalent to the Sonoline Antares (K050034), Sonoline G 60 S (K052894), Sonoline Orchid (K043016) and the Acuson CV70 (K042044), All systems transmit ultrasonic energy into patients, then perform post processing of to-ecoved echoes to generate on-screen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.

End of 510(k) Summary

2

Image /page/2/Picture/1 description: The image shows a black and white logo. The logo consists of a circular border with text around the perimeter. Inside the circle, there is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2006

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: K061946

Trade Name: ACUSON X300 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 6, 2006 Received: July 10, 2006

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the ACUSON C300 Diagnostic Ultrasound System, as described in your premarket notification:

3

Transducer Model Number
P4-2BE9-4C8-5
CH5-2CW28L3
VF10-5CW510V4
L9-5Acu Nav 8FC7F2
EC9-4Acu Nav 10FEV9F4
EV9-4V5Ms TEEL13F5 3D/4D
VF13-54V1c
P8-4VF13-5SP

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

4

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (301) 594-1212.

Sincerely yours.

Nancy Baylor

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

5

510(k) Number (if known):

K061946

Device Name:

ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | |
| Abdominal | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | |
| Intraoperative
(Note 6) | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | |
| Intraoperative
Neurological | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | |
| Pediatric | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | |
| Small Organ
(Note 1) | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | |
| Neonatal Cephalic | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | |
| Adult Cephalic | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | |
| Cardiac | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | |
| Transesophageal | N | N | N | N | N | N | N | BMDC | Note 2,3,7,8,9 | |
| Transrectal | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | |
| Transvaginal | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | |
| Transurethral | | | | | | | | | | |
| Intravascular | N | N | N | N | N | N | N | BMDC | Note 2,3,7,8,9,10 | |
| Peripheral vessel | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | |
| Musculo-skeletal
Superficial | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | |
| Other (specify) | N | N | N | N | N | N | N | BMDC | Note 2,3,7,8,9,10 | |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

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)

Diagnostic Ultrasound Indications for Use Form

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices

510(k) Number

K061946

6

510(k) Number (if known):

K061946

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:

| Clinical Application | Mode of Operation | | | | | | Combined
(Specify) | Other
(Specify) | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|-----------------------|--------------------|----------------------|------------------------------|
| | A | B | M | PWD | CWD | Color
Doppler | | | Amplitude
Doppler | Color
Velocity
Imaging |
| 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
(Note 6) | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Small Organ
(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | N | N | N | N | N | N | | 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 | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared under K043016; E = added under Appendix E

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Ensemble tissue harmonic imaging Note 2

3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

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)

P. D. M. PETERSON

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev

510(k) Number

7

510(k) Number (if known):

KD61946

CH5-2 Convex Array Transducer for use with: Device Name:

ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPBMDCNote 2,3,4,5,7,8,9
AbdominalPPPPPBMDCNote 2,3,4,5,7,8,9
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPBMDCNote 2,3,4,5,7,8,9
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
CardiacNNNNNBMDCNote 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMDCNote 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal
ConventionalNNNNNBMDCNote 2.3.4.5.7.8.9
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared under K043016; E = added under Appendix E

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

  • Note 4 B&W SieScape panoramic imaging
  • Note 5 Power SieScape panoramic imaging
  • Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

  • 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 N050/1542

8

510(k) Number (if known):

K061946

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:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalNNNNNBMDCNote 2,3,4,5,7,8,9
AbdominalPPPPPBMDCNote 2,3,4,5,7,8,9
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPBMDCNote 2,3,4,5,7,8,9
Small Organ
(Note 1)PPPPPBMDCNote 2,3,4,5,7,8,9
Neonatal CephalicPPPPPBMDCNote 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMDCNote 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal
ConventionalPPPPPBMDCNote 2,3,4,5,7,8,9
Musculo-skeletal
SuperficialPPPPPBMDCNote 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared under K043016; E = added under Appendix E

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

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, Abdomit and Radiological De

510(k) Number

Kola 19

9

510(k) Number (if known):

K061946

Device Name:

L9-5 Linear Array Transducer for use with:

ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
ABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalNNNNNBMDCNote 2.3.4.5.7.8.9
AbdominalPPPPPBMDCNote 2,3,4,5,7,8,9
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPBMDCNote 2,3,4,5,7,8,9
Small Organ
(Note 1)PPPPPBMDCNote 2,3,4,5,7,8,9
Neonatal CephalicPPPPPBMDCNote 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMDCNote 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal
ConventionalPPPPPBMDCNote 2,3,4,5,7,8,9
Musculo-skeletal
SuperficialPPPPPBMDCNote 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared under K043016; E = added under Appendix E

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Ensemble tissue harmonic imaging Note 2

3D imaqing Note 3

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 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 Devic

519(k) Number ...

K/Na 194

10

510(k) Number (if known):

K061946

Device Name:

Intended Use:

EC9-4 Convex Array Endocavity 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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPBMDCNote 2,3,4,5,7,8,9
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)NNNNNBMDCNote 2,3,4,5,7,8,9
Neonatal CephalicNNNNNBMDCNote 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
TransrectalPPPPPBMDCNote 2,3,4,5,7,8,9
TransvaginalPPPPPBMDCNote 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 under K043016; E = added under Appendix E

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic Imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent Imaging

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, Abdomina and Radiological Devices

510(k) Number

K061946

11

510(k) Number (if known):

Device Name:

Intended Use:

K D61946

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:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPBMDCNote 2,3,4,5,7,8,9
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)NNNNNBMDCNote 2,3,4,5,7,8,9
Neonatal CephalicNNNNNBMDCNote 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
TransrectalPPPPPBMDCNote 2,3,4,5,7,8,9
TransvaginalPPPPPBMDCNote 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 under K043016; 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)

(Division Sign-Off)

Divisi Reproductive, Abdominal and Ra cal Device

510(k)

12

510(k) Number @r known):

Device Name:

K061946

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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalNNNNNBMDCNote 2.3.4.5.7.8.9
AbdominalNNNNNBMDCNote 2,3,4,5,7,8,9
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPBMDCNote 2,3,4,5,7,8,9
Small Organ
(Note 1)PPPPPBMDCNote 2,3,4,5,7,8,9
Neonatal CephalicPPPPPBMDCNote 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMDCNote 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal
ConventionalPPPPPBMDCNote 2,3,4,5,7,8,9
Musculo-skeletal
SuperficialPPPPPBMDCNote 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared under K043016; 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

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)

(Division Sign-Off)
Division of Reproductive, Abdominal

Division of Reproductive, Abdominal, and Radiological Device

510(k) Number_

13

510(k) Number (if known):

K061946

P8-4 Phase Array Transducer for use with:

Device Name:

Intended Use:

ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPPBMDCNote 2,3,4,5,7,8,9
AbdominalPPPPPPBMDCNote 2,3,45,7,8,9
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPPBMDCNote 2,3,4,5,7,8,9
Small Organ
(Note 1)
Neonatal CephalicPPPPPPBMDCNote 2,3,4,5,7,8,9
Adult CephalicPPPPPPBMDCNote 2,3,4,5,7,8,9
CardiacPPPPPPBMDCNote 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethrai
Intravascular
Peripheral vesselNNNNNNBMDCNote 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal
ConventionalNNNNNNBMDCNote 2,3,4,5,7,8,9
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared under K043016(P7-4); 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)

Y. Yamazak

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number

14

510(k) Number (if known):

K061946

Device Name:

Intended Use:

ACUSON X300 Diagnostic Ultrasound Systems Diaqnostic imaging or fluid flow analysis of the human body as follows:

BE9-4 Convex Array Transducer for use with:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPBMDCNote 2,3,4,5,7,8,9
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)NNNNNBMDCNote 2,3,4,5,7,8,9
Neonatal CephalicNNNNNBMDCNote 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
TransrectalPPPPPBMDCNote 2,3,4,5,7,8,9
TransvaginalPPPPPBMDCNote 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 under K043016; E = added under Appendix E

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic Imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

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)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

15

510(k) Number (if known):

K061746

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:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalP
AbdominalP
Intraoperative
(Note 6)P
Intraoperative
Neurological
PediatricP
Small Organ
(Note 1)P
Neonatal CephalicP
Adult CephalicP
CardiacP
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselP
Laparoscopic
Musculo-skeletal
ConventionalP
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared under K001400; 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

  • For example: abdominal, vascular Note 6
    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)

D. Lawrence Harrington

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dey 510(k) Number

16

510(k) Number (if known):

K061946

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:

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | P | | | | | |
| Abdominal | | | | | P | | | | | |
| Intraoperative
(Note 6) | | | | | P | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ
(Note 1) | | | | | P | | | | | |
| Neonatal Cephalic | | | | | P | | | | | |
| Adult Cephalic | | | | | P | | | | | |
| Cardiac | | | | | P | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | P | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared under K023720; 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

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 NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Division Size: 080

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number

17

510(k) Number (if known):

Device Name:

Intended Use:

K061746

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:

Clinical ApplicationMode of Operation
-----------------------------------------
ABMPWDCWDColor DopplerAmplitude DopplerColor Velocity ImagingCombined (Specify)Other (Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPPBMDCNote 2,3,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
IntravascularPPPPPPPBMDCNote 2,3,7,8,9,10
Peripheral vessel
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (Intra-Cardiac)PPPPPPPBMDCNote 2,3,7,8,9,10

N = new indication; P = previously cleared under K042593; E = added under Appendix E

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

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)

Prescription Use (Per 21 CFR 801.109)

limitation

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological De

510(k) Number K961946

18

510(k) Number (if known):

Device Name:

06194

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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPBMDCNote 2,3,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
IntravascularPPPPPPBMDCNote 2,3,7,8,9,10
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (Intra-Cardiac)PPPPPPBMDCNote 2,3,7,8,9,10

N = new indication; P = previously cleared under K033650; 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

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular 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)

Prescription Use (Per 21 CFR 801.109)

J. Henry Carpenter

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological D

5.10(k) Number K0619

19

510(k) Number (if known):

Device Name:

K061946

Intended Use:

V5Ms TEE Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
ABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
TransesophagealPPPPPPBMDCNote 2,3,7,8,9
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared under K022567; E = added under Appendix E

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

Note 3 3D Imaging

Note 4 B&W SieScape panoramic Imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

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)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominai,
and Radiological Devices
510(k) Number KDe 1946

20

061946

510(k) Number @r known):

Device Name:

Intended Use:

4V1c Phased 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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPPBMDCNote 2,3,4,5,7,8,9
AbdominalPPPPPPBMDCNote 2,3,5,6,7,8,9
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPPBMDCNote 2,3,4,5,7,8,9
Small Organ
(Note 1)
Neonatal CephalicNNNNNNBMDCNote 2,3,4,5,7,8,9
Adult CephalicNNNNNNBMDCNote 2,3,4,5,7,8,9
CardiacPPPPPPBMDCNote 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPPBMDCNote 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared under K022567; E = added under Appendix E

Note 1 For example: breast, testes, thyroid, penis, prostate, etc

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

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,

Radiological Devices
510(k) Number K061946

21

510(k) Number (if known):

K061946

Device Name:

Intended Use:

VF13-5SP 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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
(Note 6)PPPPPBMDCNote 2,3,4,5,7,8,9
Intraoperative
NeurologicalPPPPPBMDCNote 2,3,4,5,7,8,9
PediatricPPPPPBMDCNote 2,3,4,5,7,8,9
Small Organ
(Note 1)PPPPPBMDCNote 2,3,4,5,7,8,9
Neonatal CephalicNNNNNBMDCNote 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMDCNote 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal
ConventionalPPPPPBMDCNote 2,3,4,5,7,8,9
Musculo-skeletal
SuperficialPPPPPBMDCNote 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared under K023720; E = added under Appendix E

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Ensemble tissue harmonic imaging Note 2

3D Imaging Note 3

B&W SieScape panoramic Imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

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)

Prescription Use (Per 21 CFR 801.109)

S. Vinton, C. Douglas

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

22

510(k) Number (if known):

K061946

Device Name:

Intended Use:

C8-5 Tight Curved 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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalNNNNNBMDCNote 2,3,4,5,7,8,9
AbdominalPPPPPBMDCNote 2,3,5,6,7,8,9
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPBMDCNote 2,3,4,5,7,8,9
Small Organ
(Note 1)PPPPP
Neonatal CephalicPPPPPBMDCNote 2,3,4,5,7,8,9
Adult CephalicNNNNNBMDCNote 2,3,4,5,7,8,9
CardiacNNNNNBMDCNote 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselNNNNNBMDCNote 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal
ConventionalPPPPP
Musculo-skeletal
SuperficialNNNNN

N = new indication; P = previously cleared under K020353; E = added under Appendix E

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Ensemble tissue harmonic imaging Note 2

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 Koce 1946

23

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 ApplicationMode of Operation
ABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalNNNNNBMDCNote 2,3,4,5,7,8,9
AbdominalPPPPPBMDCNote 2,3,4,5,7,8,9
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricNNNNNBMDCNote 2,3,4,5,7,8,9
Small Organ
(Note 1)PPPPPBMDCNote 2,3,4,5,7,8,9
Neonatal CephalicNNNNNBMDCNote 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMDCNote 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal
ConventionalPPPPPBMDCNote 2,3,4,5,7,8,9
Musculo-skeletal
SuperficialNNNNNBMDCNote 2,3,4,5,7,8,9
Other (specify)

061946

8L3 Linear "Regel" Transducer for use with :

N = new indication; P = previously cleared under K020353(5.0L45); E = added under Appendix E

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

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)

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(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Dev 510(k) Number

24

510(k) Number (if known):

K061746

Device Name:

10V4 Phased Array Neonatal High Frequency 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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPPBMDCNote 2,3,4,5,7,8,9
AbdominalPPPPPPBMDCNote 2,3,4,5,7,8,9
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPPBMDCNote 2,3,4,5,7,8,9
Small Organ
(Note 1)
Neonatal CephalicPPPPPPBMDCNote 2,3,4,5,7,8,9
Adult Cephalic
CardiacPPPPPPBMDCNote 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselNNNNNNBMDCNote 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal
ConventionalNNNNNNBMDCNote 2,3,4,5,7,8,9
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared under K022567; E = added under Appendix E

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Ensemble tissue harmonic imaging Note 2

3D imaqing 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)

L
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061946

25

510(k) Number (if known):

K 1061946

Device Name:

Intended Use:

C7F2 Curved array mechanical 3D/4D 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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPBMDCNote 2,3,4,5,7,8,9
AbdominalPPPPPBMDCNote 2,3,4,5,7,8,9
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPBMDCNote 2,3,4,5,7,8,9
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
CardiacNNNNNBMDCNote 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMDCNote 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal
ConventionalPPPPPBMDCNote 2.3.4.5.7.8.9
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared under K023720; 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

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

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)

D'Alembert

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Device

510(k) Number -

26

510(k) Number (if known):

K061946

Device Name:

Intended Use:

EV9F4 Curved array mechanical 3D/4D 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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPBMDCNote 2,3,4,5,7,8,9
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)PPPPPBMDCNote 2,3,4,5,7,8,9
Neonatal CephalicPPPPPBMDCNote 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
TransrectalNNNNNBMDCNote 2,3,4,5,7,8,9
TransvaginalPPPPPBMDCNote 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 under K050034; 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

Contrast agent imaging Note 7

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 Sign-Off)
Division of Reproductive, Abdominal.
and Radiological Devices
510(k) Number, K061946

27

K061946

Device Name:

intended Use:

L13F5 3D/4D mechanical wobbler linear 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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPBMDCNote 2,3,4,5,7,8,9
AbdominalPPPPPBMDCNote 2,3,4,5,7,8,9
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPBMDCNote 2,3,4,5,7,8,9
Small Organ
(Note 1)PPPPPBMDCNote 2,3,4,5,7,8,9
Neonatal CephalicPPPPPBMDCNote 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMDCNote 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal
ConventionalPPPPPBMDCNote 2,3,4,5,7,8,9
Musculo-skeletal
SuperficialPPPPPBMDCNote 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared under K023720(C7F2 Wobbler) and K043016(VF13-5 Linear);

E = added under Appendix E

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Ensemble tissue harmonic imaging Note 2

3D imaging Note 3

B&W SieScape panoramic Imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

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)

  1. Imerse 202-762

(Division Sign-Off) (Division Sign of Reproductive, Abdomi and Radiological Devig 510(k) Number