LogoFDA 510(k) Search
K Number
K072676
Device Name
ACUSON X300 ULTRASOUND SYSTEM
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC.
Date Cleared
2007-12-18

(88 days)

Product Code
IYODQOITXIYN
Regulation Number
892.1560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (abdominal, vascular), Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Intravascular, Peripheral vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
Device Description
The Siemens Acuson X300 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.
More Information

K071036, K061946

Not Found

No
The document does not mention AI, ML, or related terms, nor does it describe any features or processes that are characteristic of AI/ML applications in medical imaging (e.g., automated detection, segmentation, or analysis driven by learned models). The description focuses on standard ultrasound system functionalities and applications.

No
The device is described as an "ultrasound imaging system" and a "multi-purpose diagnostic ultrasound system," and its intended use is for "diagnostic imaging" and for analysis that provides "information that is used for clinical diagnosis purposes." This indicates it is used for diagnosis, not treatment.

Yes
The "Intended Use / Indications for Use" section states: "The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes." The "Device Description" also explicitly states: "The Siemens Acuson X300 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software."

No

The device description explicitly states it is a "multi-purpose diagnostic ultrasound system with accessories and proprietary software," indicating it includes hardware components in addition to software.

Based on the provided information, the Siemens Acuson X300 ultrasound imaging system is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device function: The Siemens Acuson X300 is an ultrasound imaging system. It uses sound waves to create images of internal body structures. This is an in vivo diagnostic method (performed within the living body), not an in vitro method.
  • Intended Use: The intended use clearly describes imaging applications for various anatomical sites within the human body.
  • Device Description: The description confirms it's a diagnostic ultrasound system.

Therefore, the Siemens Acuson X300 falls under the category of medical imaging devices, not in vitro diagnostics.

N/A

Intended Use / Indications for Use

The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (Note 6), Intraoperative Neurological, Pediatric, Small Organ (Note 1), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Intravascular, Peripheral vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Other (specify).

P5-1 Phased Array Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral vessel.

Product codes (comma separated list FDA assigned to the subject device)

74-DQO, 90-IYN, 90-IYO, 90-ITX

Device Description

The Siemens Acuson X300 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Intraoperative, Pediatric, Small Parts (e.g., breast, testes, thyroid, penis, prostate), Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular.

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)

The Acuson X300 modifications are verified and validated according to the company's design control process.

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.

K071036, K061946

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

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

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K072676

Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON X300™ Ultrasound System Special 510(k) Submission

Product Code 74-DQO

SECTION 11

510(k) Summary

| Sponsor: | Siemens Medical Solutions USA, Inc.,
Ultrasound Division
1230 Shorebird Way
Mountain View, California 94043 | | | DEC 1 8 2007 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------|--|--------------|
| Contact Person: | Martina Vogt | | | |
| | Telephone: | (425) 557 1434 | | |
| | Fax: | (425) 391 9198 | | |
| Submission Date: | September 19, 2007 | | | |
| Device Name: | ACUSON X300™ Diagnostic Ultrasound System
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 | | |

A. Legally Marketed Predicate Devices

Diagnostic Intravascular Catheter

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 (K071036, K061946).

FR # 870.1200

B. Device Description:

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

  • 동 UL 60601-1, Safety Requirements for Medical Equipment
  • E IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
  • CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
  • I AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
  • AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
  • I 93/42/EEC Medical Devices Directive
  • Safety and EMC Requirements for Medical Equipment
    • 트 EN/IEC 60601-1
    • . EN/IEC 60601-1-1
    • EN/IEC 60601-1-2
  • 트 IEC 61157 Declaration of Acoustic Power
  • 1 ISO 10993-1 Biocompatibility

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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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2007

Ms. Martina Vogt Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 1230 Shorebird Way MOUNTAIN VIEW CA 94043

Re: K072676

Trade/Device Name: ACUSON X300 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and DQO Dated: November 14, 2007 Received: November 15, 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

P5-1 Phased Array

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any

3

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

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 Lauren Hefner at (240) 276-3666.

Sincerely yours,

Nancy C. Brogdon

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

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SECTION 7

Intended Use of the Device

Intended Use:

The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

forui Thihhay

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _ HO72 Co

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Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

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
FetalPPPPPPBMDCNote 2,3,4,5,7,8,9
AbdominalPPPPPPBMDCNote 2,3,4,5,7,8,9
Intraoperative
(Note 6)PPPPPPBMDCNote 2,3,4,5,7,8,9
Intraoperative
NeurologicalPPPPPBMDCNote 2,3,4,5,7,8,9
PediatricPPPPPPBMDCNote 2,3,4,5,7,8,9
Small Organ
(Note 1)PPPPPPBMDCNote 2,3,4,5,7,8,9
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
TransesophagealPPPPPPBMDCNote 2,3,7,8,9
TransrectalPPPPPBMDCNote 2,3,4,5,7,8,9
TransvaginalPPPPPBMDCNote 2,3,4,5,7,8,9
Transurethral
IntravascularPPPPPPBMDCNote 2,3,7,8,9,10
Peripheral vesselPPPPPPBMDCNote 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal
ConventionalPPPPPPBMDCNote 2,3,4,5,7,8,9
Musculo-skeletal
SuperficialPPPPPPBMDCNote 2,3,4,5,7,8,9
Other (specify)PPPPPPBMDCNote 2,3,7,8,9,10

N = new indication; P = previously cleared by K071036; 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

Note 7 Contrast agent imaging

  • SieClear multi-view spatial compounding Note 8
  • Tissue Equalization Technology Note 9
  • Note 10 Intracardiac imaging

etc.
(Division Sign-Off)

Division of Reproductive, Abdominal Radiological Devices 510(k) Number J KO + 26

(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)

6

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

P5-1 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
FetalNNNNNNBMDCNote 2,3,4,5,7,8,9
AbdominalNNNNNNBMDCNote 2,3,5,6,7,8,9
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricNNNNNNBMDCNote 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
CardiacNNNNNNBMDCNote 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselNNNNNNBMDCNote 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)
N = new indication; P = previously cleared by FDA; E = added under Appendix/E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging

vote 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

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

Radiological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)