(27 days)
The ACUSON P600 ultrasound imaging system is intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gynecological, Intraoperative, and Urological applications using different ultrasound transducers for different applications.
The system also provides the ability to measure anatomical structures analysis packages that provide information used by a physician for clinical diagnosis purposes.
Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular svstem.
This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."
The ACUSON P600 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
This document does not contain explicit acceptance criteria and corresponding study results with performance metrics that would typically be reported in a clinical trial. Instead, it is a 510(k) summary for the ACUSON P600 Diagnostic Ultrasound System, asserting substantial equivalence to previously cleared predicate devices.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Claim)
The document does not detail specific quantitative acceptance criteria or performance metrics for the ACUSON P600 Diagnostic Ultrasound System itself because it aims to demonstrate "substantial equivalence" to existing, legally marketed predicate devices, rather than proving novel performance.
The "Substantial Equivalence" table (pages 22-23) serves as a comparison of features and intended uses between the submission device (ACUSON P600) and its predicate devices (ACUSON X700, ACUSON SC2000, ACUSON S2000, ACUSON P500). For each listed indication, mode, and feature, the presence ("√") or absence ("-") in both the predicate and submission device is noted. All features present in the ACUSON X700 (K141846), which is used as the primary predicate for most features, are indicated as being present in the ACUSON P600. Similarly, some features from other predicates (SC2000, S2000, P500) are also indicated as being present in the ACUSON P600.
Therefore, the "acceptance criteria" here is that the ACUSON P600 meets the same intended uses, modes, and features as the predicate devices. The "reported device performance" is implicitly that it performs equivalently to these cleared devices, as no new performance claims are being made that would require specific new benchmarks.
Study Information:
1. A table of acceptance criteria and the reported device performance
As explained above, explicit quantitative acceptance criteria for performance are not provided. The study relies on demonstrating feature equivalence to predicate devices. The table on pages 22-23 serves as the comparison for "acceptance criteria" (i.e., matching predicate features) and "reported device performance" (i.e., presence of those features in the P600).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Since the ACUSON P600 Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical data is not required." (Page 25) This indicates that no new clinical test set was used to establish performance. Therefore, there is no information on sample size, data provenance, or retrospective/prospective nature of a clinical test set. The submission relies on non-clinical tests (Page 24) to ensure safety and effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical test set was required or performed for performance evaluation in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was required or performed for performance evaluation in this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device clearance for a diagnostic ultrasound system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new clinical test set was used to establish performance. The ground truth for substantiating the predicate devices would have been previously established through their respective clearance processes.
8. The sample size for the training set
Not applicable, as no new clinical test set or algorithm training is mentioned for this 510(k) submission. The device relies on
"the same technology and principles as existing devices."
9. How the ground truth for the training set was established
Not applicable, as no training set for a new algorithm is mentioned in this document.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The text reads U.S. FOOD & DRUG ADMINISTRATION.
Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, Nw Buffalo, Minnesota 55313
February 5, 2018
Re: K180039
Trade/Device Name: ACUSON P600 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 3, 2018 Received: January 5, 2018
Dear Mark Job:
This letter corrects our substantially equivalent letter of February 1, 2018.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@)da.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Balyer
for Robert A. Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180039
Device Name
ACUSON P600 Diagnostic Ultrasound System
Indications for Use (Describe)
The ACUSON P600 ultrasound imaging system is intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gynecological, Intraoperative, and Urological applications using different ultrasound transducers for different applications.
The system also provides the ability to measure anatomical structures analysis packages that provide information used by a physician for clinical diagnosis purposes.
Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular svstem.
This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
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510(k) Number (if known):
ACUSON P600™ Diagnostic Ultrasound System
Device Name: Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | N | N | N | N | N | BCDM | ||
| Obstetrics(Note 2) | N | N | N | N | N | BCDM | ||
| Gynecology(Note 3) | N | N | N | N | N | BCDM | ||
| Small Parts(Note 4) | N | N | N | N | N | BCDM | ||
| Pediatric(Note 5) | N | N | N | N | N | N | BCDM | |
| Neonatal(Note 6) | N | N | N | N | N | N | BCDM | |
| Vascular(Note 7) | N | N | N | N | N | N | BCDM | |
| Urology(Note 8) | N | N | N | N | N | BCDM | ||
| Echocardiography(Note 9) | N | N | N | N | N | N | BCDM | |
| Musculoskeletal(Note 10) | N | N | N | N | N | BCDM | ||
| Intraoperative(Note 11) | N | N | N | N | N | BCDM |
N = new indication; P = previously cleared
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Number (if known):
Device Name: Intended Use: 5C1 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
Clinical Mode of Operation Application 2D Color Power Combined Other M PWD CWD (B) Doppler Doppler (Specify) (Specify)
| Ophthalmic | ||||||
|---|---|---|---|---|---|---|
| Abdominal(Note 1) | N | N | N | N | N | BCDM |
| Obstetrics(Note 2) | N | N | N | N | N | BCDM |
| Gynecology(Note 3) | N | N | N | N | N | BCDM |
| Small Parts(Note 4) | ||||||
| Pediatric(Note 5) | ||||||
| Neonatal(Note 6) | ||||||
| Vascular(Note 7) | N | N | N | N | N | BCDM |
| Urology(Note 8) | N | N | N | N | N | BCDM |
| Echocardiography(Note 9) | ||||||
| Musculoskeletal(Note 10) | N | N | N | N | N | BCDM |
| Intraoperative(Note 11) |
N = new indication; P = previously cleared
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Number (if known):
Device Name:
Intended Use:
5P1 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | N | N | N | N | N | BCDM | ||
| Obstetrics(Note 2) | ||||||||
| Gynecology(Note 3) | ||||||||
| Small Parts(Note 4) | ||||||||
| Pediatric(Note 5) | ||||||||
| Neonatal(Note 6) | ||||||||
| Vascular(Note 7) | N | N | N | N | N | BCDM | ||
| Urology(Note 8) | ||||||||
| Echocardiography(Note 9) | N | N | N | N | N | BCDM | ||
| Musculoskeletal(Note 10) | ||||||||
| Intraoperative(Note 11) |
N = new indication; P = previously cleared
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Number (if known):
Device Name: Intended Use: 11L4 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | N | N | N | N | N | N | BCDM | |
| Obstetrics(Note 2) | N | N | N | N | N | N | BCDM | |
| Gynecology(Note 3) | ||||||||
| Small Parts(Note 4) | N | N | N | N | N | N | BCDM | |
| Pediatric(Note 5) | N | N | N | N | N | N | BCDM | |
| Neonatal(Note 6) | ||||||||
| Vascular(Note 7) | N | N | N | N | N | N | BCDM | |
| Urology(Note 8) | ||||||||
| Echocardiography(Note 9) | ||||||||
| Musculoskeletal(Note 10) | N | N | N | N | N | N | BCDM | |
| Intraoperative(Note 11) |
N = new indication; P = previously cleared
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Number (if known):
Device Name: Intended Use:
12L3 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | N | N | N | N | N | BCDM | ||
| Obstetrics(Note 2) | N | N | N | N | N | BCDM | ||
| Gynecology(Note 3) | ||||||||
| Small Parts(Note 4) | N | N | N | N | N | BCDM | ||
| Pediatric(Note 5) | N | N | N | N | N | BCDM | ||
| Neonatal(Note 6) | ||||||||
| Vascular(Note 7) | N | N | N | N | N | BCDM | ||
| Urology(Note 8) | ||||||||
| Echocardiography(Note 9) | ||||||||
| Musculoskeletal(Note 10) | N | N | N | N | N | BCDM | ||
| Intraoperative(Note 11) |
N = new indication; P = previously cleared
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Number (if known):
Device Name: Intended Use:
16L4 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | N | N | N | N | N | BCDM | ||
| Obstetrics(Note 2) | ||||||||
| Gynecology(Note 3) | ||||||||
| Small Parts(Note 4) | N | N | N | N | N | BCDM | ||
| Pediatric(Note 5) | N | N | N | N | N | BCDM | ||
| Neonatal(Note 6) | ||||||||
| Vascular(Note 7) | N | N | N | N | N | BCDM | ||
| Urology(Note 8) | ||||||||
| Echocardiography(Note 9) | ||||||||
| Musculoskeletal(Note 10) | N | N | N | N | N | BCDM | ||
| Intraoperative(Note 11) |
N = new indication; P = previously cleared
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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{9}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use:
18H5 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | ||||||||
| Obstetrics(Note 2) | ||||||||
| Gynecology(Note 3) | ||||||||
| Small Parts(Note 4) | N | N | N | N | N | BCDM | ||
| Pediatric(Note 5) | ||||||||
| Neonatal(Note 6) | ||||||||
| Vascular(Note 7) | N | N | N | N | N | BCDM | ||
| Urology(Note 8) | ||||||||
| Echocardiography(Note 9) | ||||||||
| Musculoskeletal(Note 10) | N | N | N | N | N | BCDM | ||
| Intraoperative(Note 11) | N | N | N | N | N | BCDM |
N = new indication; P = previously cleared
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Number (if known):
Device Name: Intended Use: 9VE3 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | ||||||||
| Obstetrics(Note 2) | N | N | N | N | N | BCDM | ||
| Gynecology(Note 3) | N | N | N | N | N | BCDM | ||
| Small Parts(Note 4) | ||||||||
| Pediatric(Note 5) | ||||||||
| Neonatal(Note 6) | ||||||||
| Vascular(Note 7) | ||||||||
| Urology(Note 8) | ||||||||
| Echocardiography(Note 9) | ||||||||
| Musculoskeletal(Note 10) | ||||||||
| Intraoperative(Note 11) |
N = new indication; P = previously cleared
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)
{11}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use: 8VC3 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | N | N | N | N | N | N | BCDM | |
| Obstetrics(Note 2) | N | N | N | N | N | N | BCDM | |
| Gynecology(Note 3) | N | N | N | N | N | N | BCDM | |
| Small Parts(Note 4) | ||||||||
| Pediatric(Note 5) | ||||||||
| Neonatal(Note 6) | ||||||||
| Vascular(Note 7) | ||||||||
| Urology(Note 8) | ||||||||
| Echocardiography(Note 9) | ||||||||
| Musculoskeletal(Note 10) | ||||||||
| Intraoperative(Note 11) |
N = new indication; P = previously cleared
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{12}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use:
10MC3 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | ||||||||
| Obstetrics(Note 2) | N | N | N | N | N | BCDM | ||
| Gynecology(Note 3) | N | N | N | N | N | BCDM | ||
| Small Parts(Note 4) | ||||||||
| Pediatric(Note 5) | ||||||||
| Neonatal(Note 6) | ||||||||
| Vascular(Note 7) | ||||||||
| Urology(Note 8) | N | N | N | N | N | BCDM | ||
| Echocardiography(Note 9) | ||||||||
| Musculoskeletal(Note 10) | ||||||||
| Intraoperative(Note 11) |
N = new indication; P = previously cleared
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{13}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use: 9MC3 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | ||||||||
| Obstetrics(Note 2) | N | N | N | N | N | BCDM | ||
| Gynecology(Note 3) | N | N | N | N | N | BCDM | ||
| Small Parts(Note 4) | ||||||||
| Pediatric(Note 5) | ||||||||
| Neonatal(Note 6) | ||||||||
| Vascular(Note 7) | ||||||||
| Urology(Note 8) | N | N | N | N | N | BCDM | ||
| Echocardiography(Note 9) | ||||||||
| Musculoskeletal(Note 10) | ||||||||
| Intraoperative(Note 11) |
N = new indication; P = previously cleared
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{14}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use:
10V4 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | ||||||||
| Obstetrics(Note 2) | ||||||||
| Gynecology(Note 3) | ||||||||
| Small Parts(Note 4) | ||||||||
| Pediatric(Note 5) | P | P | P | P | P | P | BCDM | |
| Neonatal(Note 6) | P | P | P | P | P | P | BCDM | |
| Vascular(Note 7) | ||||||||
| Urology(Note 8) | ||||||||
| Echocardiography(Note 9) | P | P | P | P | P | P | BCDM | |
| Musculoskeletal(Note 10) | ||||||||
| Intraoperative(Note 11) |
N = new indication; P = previously cleared (K163635)
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{15}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
8V4 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | ||||||||
| Obstetrics(Note 2) | ||||||||
| Gynecology(Note 3) | ||||||||
| Small Parts(Note 4) | ||||||||
| Pediatric(Note 5) | N | N | N | N | N | N | BCDM | |
| Neonatal(Note 6) | N | N | N | N | N | N | BCDM | |
| Vascular(Note 7) | ||||||||
| Urology(Note 8) | ||||||||
| Echocardiography(Note 9) | N | N | N | N | N | N | BCDM | |
| Musculoskeletal(Note 10) | ||||||||
| Intraoperative(Note 11) |
N = new indication; P = previously cleared
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{16}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
7C2 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | N | N | N | N | N | N | BCDM | |
| Obstetrics(Note 2) | N | N | N | N | N | N | BCDM | |
| Gynecology(Note 3) | N | N | N | N | N | N | BCDM | |
| Small Parts(Note 4) | ||||||||
| Pediatric(Note 5) | N | N | N | N | N | N | BCDM | |
| Neonatal(Note 6) | ||||||||
| Vascular(Note 7) | ||||||||
| Urology(Note 8) | N | N | N | N | N | N | BCDM | |
| Echocardiography(Note 9) | ||||||||
| Musculoskeletal(Note 10) | N | N | N | N | N | N | BCDM | |
| Intraoperative(Note 11) |
N = new indication; P = previously cleared
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{17}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use:
11M3 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | ||||||||
| Obstetrics(Note 2) | ||||||||
| Gynecology(Note 3) | ||||||||
| Small Parts(Note 4) | ||||||||
| Pediatric(Note 5) | N | N | N | N | N | BCDM | ||
| Neonatal(Note 6) | N | N | N | N | N | BCDM | ||
| Vascular(Note 7) | N | N | N | N | N | BCDM | ||
| Urology(Note 8) | ||||||||
| Echocardiography(Note 9) | N | N | N | N | N | BCDM | ||
| Musculoskeletal(Note 10) | ||||||||
| Intraoperative(Note 11) |
N = new indication; P = previously cleared
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{18}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use:
CW2 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | ||||||||
| Obstetrics(Note 2) | ||||||||
| Gynecology(Note 3) | ||||||||
| Small Parts(Note 4) | ||||||||
| Pediatric(Note 5) | ||||||||
| Neonatal(Note 6) | ||||||||
| Vascular(Note 7) | ||||||||
| Urology(Note 8) | ||||||||
| Echocardiography(Note 9) | P | |||||||
| Musculoskeletal(Note 10) | ||||||||
| Intraoperative(Note 11) |
N = new indication; P = previously cleared (K163635)
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{19}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use:
CW5 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| 2D(B) | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||
| Abdominal(Note 1) | ||||||||
| Obstetrics(Note 2) | ||||||||
| Gynecology(Note 3) | ||||||||
| Small Parts(Note 4) | ||||||||
| Pediatric(Note 5) | ||||||||
| Neonatal(Note 6) | ||||||||
| Vascular(Note 7) | P | |||||||
| Urology(Note 8) | ||||||||
| Echocardiography(Note 9) | P | |||||||
| Musculoskeletal(Note 10) | ||||||||
| Intraoperative(Note 11) |
N = new indication; P = previously cleared (K163635)
| Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) |
|---|---|
| Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) |
| Note 3 | Gynecology (Gynecology, Pelvic Floor) |
| Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) |
| Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) |
| Note 6 | Neonatal (Neonatal Head) |
| Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) |
| Note 8 | Urology (Pelvis, Prostate) |
| Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) |
| Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) |
| Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{20}------------------------------------------------
510(k) Summary
| Date: | August 31, 2017 | ||
|---|---|---|---|
| Submitter: | Siemens Medical Solutions USA, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043 | ||
| Manufacturing Facility: | Siemens Healthcare Ltd.2nd -3rd floor, 143, Sunhwan-ro,Jungwon-gu, Seongnam-si, Gyeonggi-do,Republic of Korea | ||
| Contact Person: | Sulgue ChoiTel: (425) 281-9898 | ||
| Device Name: | ACUSON P600 Diagnostic Ultrasound System | ||
| Common Name: | Diagnostic Ultrasound System with Accessories | ||
| Classification: | Regulatory Class: IIReview Category: Tier IIClassification Panel: Radiology | ||
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN | |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO | |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
A. Legally Marketed Predicate Devices
The ACUSON P600 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current products, the ACUSON X700 (K141846), ACUSON S2000 (K163635), ACUSON P500 (K163396) and ACUSON SC2000 (K170315).
{21}------------------------------------------------
B. Device Description
The ACUSON P600 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
C. Intended Use
The ACUSON P600 ultrasound imaging system is intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical. Gynecological. Intraoperative, and Urological applications using different ultrasound transducers for different applications.
The system also provides the ability to measure anatomical structures and analysis packages that provide information that is used by a physician for clinical diagnosis purposes.
Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients reqarding state of their cardiovascular system.
This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."
D. Substantial Equivalence
The ACUSON P600 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current products, the ACUSON X700 (K141846), ACUSON SC2000 (K170315), ACUSON S2000 (K163635) and ACUSON P500 (K163396). All systems transmit ultrasonic energy into patients, and then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.
The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.
{22}------------------------------------------------
ACUSON P600 Diagnostic Ultrasound System 510(k) Submission
| PredicateDeviceACUSON X700(K141846) | PredicateDeviceACUSONSC2000(K170315) | PredicateDeviceACUSONS2000(K163635) | PredicateDeviceACUSONP500(K163396) | SubmissionDeviceACUSON P600 | |
|---|---|---|---|---|---|
| Indications for Use: | |||||
| ■Abdominal(Abdominal, Renal, Bowel,Focused Assessment withSonography for Trauma,Lung) | √ | - | - | - | √ |
| ■Obstetrics(Obstetrics, EarlyObstetrics, FetalEchocardiography,Advanced Obstetrics) | √ | - | - | - | √ |
| ■ Gynecology(Gynecology, Pelvic Floor) | √ | - | - | - | √ |
| ■ Small Parts(Breast, Testicles, Penile,Thyroid) | √ | - | - | - | √ |
| ■Pediatric(Pediatric Hip Joint,Pediatric Abdomen) | √ | - | - | - | √ |
| ■Neonatal(Neonatal Head) | √ | - | - | - | √ |
| ■ Vascular(Carotid, PeripheralVenous, PeripheralArterials, TranscranialDoppler) | √ | - | - | - | √ |
| ■Urology(Pelvis, Prostate) | √ | - | - | - | √ |
| ■ Echocardiography(Adult Echocardiography,Pediatric Echocardiography,NeonatalEchocardiography) | √ | - | - | - | √ |
| ■Musculoskeletal(Spine, Musculoskeletal,Digital, Nerve) | √ | - | - | - | √ |
| ■Intraoperative(Intraoperative Abdomen,Intraoperative Vascular) | √ | - | - | - | √ |
| Modes: | |||||
| ■2D (Brightness mode) | √ | - | - | - | √ |
| ■ C (Color Flow Doppler) | √ | - | - | - | √ |
| ■D (Doppler) | √ | - | - | - | √ |
| PredicateDeviceACUSON X700(K141846) | PredicateDeviceACUSONSC2000(K170315) | PredicateDeviceACUSONS2000(K163635) | PredicateDeviceACUSONP500(K163396) | SubmissionDeviceACUSON P600 | |
| ■ M (Motion Mode) | √ | - | - | - | √ |
| ■ CW (Continuous WaverDoppler) | √ | - | - | - | √ |
| Features: | |||||
| ■ DICOM (3.0 Connectivity,Worklist, MPPS) | √ | - | - | - | √ |
| ■ DICOM SR OB/GYN | √ | - | - | - | √ |
| ■ DICOM SR Cardiac | √ | - | - | - | √ |
| ■ DICOM SR Vascular | √ | - | - | - | √ |
| ■ syngo Arterial HealthPackage (AHP) | √ | - | - | - | √ |
| ■ syngo Auto Follicle | √ | - | - | - | √ |
| ■ syngo Auto OB | √ | - | - | - | √ |
| ■ eSie Left Heart (eSie LH) | - | √ | - | - | √ |
| ■ Stress Echo | √ | - | - | - | √ |
| ■ 3-Scape Imaging | - | - | √ | - | √ |
| ■ fourSight 4D | √ | - | - | - | √ |
| ■ Advanced fourSight 4DImaging | - | - | √ | - | √ |
| ■ eSie Touch ElasticityImaging | √ | - | - | - | √ |
| ■ eSie Measure WorkflowAcceleration Package | - | - | - | √ | √ |
| ■ eSieScan WorkflowProtocol | - | - | - | √ | √ |
| ■ Virtual Touch Quantification(VTQ) | - | - | √ | - | √ |
| ■ SieScape PanoramicImaging | √ | - | - | - | √ |
| ■ Dynamic Tissue ContrastEnhancement (DTCE) | √ | - | - | - | √ |
| ■ Advanced SieClear (ASC) | √ | - | - | - | √ |
| ■ Clarify VascularEnhancement (Clarify VE) | √ | - | - | - | √ |
| ■ eSielmage (TEQ/TGO) | - | - | √ | - | √ |
| PredicateDeviceACUSON X700(K141846) | PredicateDeviceACUSONSC2000(K170315) | PredicateDeviceACUSONS2000(K163635) | PredicateDeviceACUSONP500(K163396) | SubmissionDeviceACUSON P600 | |
| ■ Anatomical M-mode (AMM) | √ | - | - | - | √ |
| ■ HD Zoom (Res) | √ | - | - | - | √ |
| ■ Needle Visualization | - | - | - | √ | √ |
| ■ Tissue Harmonic Imaging (THI) | √ | - | - | - | √ |
| ■ Doppler Tissue Imaging (DTI) | √ | - | - | - | √ |
| ■ Custom Tissue Imaging (CTI) | - | - | √ | - | √ |
| ■ eSieCalcs | - | - | √ | - | √ |
| ■ Wireless | √ | - | - | - | √ |
| ■ Veterinary(VET) Imaging | √ | - | - | - | √ |
| ■ US Security (Virus Protection) | √ | - | - | - | √ |
{23}------------------------------------------------
ACUSON P600 Diagnostic Ultrasound System 510(k) Submission
{24}------------------------------------------------
E. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and have been found to conform to applicable medical device safety standards. The systems comply with the following voluntary standards:
- ANSI/AAMI ES 60601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical ■ Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- IEC 62359, Test methods for the determination of thermal and mechanical indices
- 트 IEC 60601-1-2
- 트 IEC 60601-2-18
- IEC 60601-2-37 트
- ISO 10993-1
- 트 ISO 14971
{25}------------------------------------------------
F. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Since the ACUSON P600 Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical data is not required.
G. Summary
Intended uses and other kev features are consistent with traditional clinical practice and FDA quidelines. The design and development process of the manufacturer conforms to 21 CFR 820 Quality System Requlation and ISO 13485:2003 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound system has accumulated a long history of safe and effective performance. Therefore, it is the opinion of Siemens Medical Solutions USA. Inc. that the ACUSON P600 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
The ACUSON P600 Diagnostic Ultrasound System is verified and validated according to the company's design control process.
§ 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.