(29 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the descriptions of the device and its functions do not mention any AI/ML capabilities.
No.
The device is described as a "diagnostic ultrasound system" and its intended use is for "visualization" and "clinical diagnosis purposes" by providing information to the clinician. It does not mention treating or preventing a disease or condition.
Yes.
The device is explicitly described as a "software controlled diagnostic ultrasound system" in the "Device Description" section, and the "Intended Use / Indications for Use" section states that the system provides "information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes."
No
The device description explicitly states it is a "multi-purpose mobile, software controlled diagnostic ultrasound system" and describes its function in acquiring and displaying ultrasound echo data, which requires hardware components (transducer, processing unit, display).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the system as an ultrasound imaging system for various anatomical sites and applications. It focuses on visualization, measurement of anatomical structures, and providing information to the clinician for diagnosis. While the information is used adjunctively for clinical diagnosis, the device itself is not performing a test on a biological sample in vitro.
- Device Description: The device description details the technical aspects of the ultrasound system, including its modes of operation and display capabilities. It describes how it acquires and displays ultrasound data, which is a form of medical imaging, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of the device analyzing biological samples (like blood, urine, tissue, etc.) or performing tests on these samples outside of the body. IVDs are specifically designed for this purpose.
The device is clearly a medical imaging device used for diagnostic purposes, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, small organ, neonatal cephalic, adult cephalic, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography: Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The ACUSON AcuNav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatic patients.
Product codes
IYN, IYO, ITX, OBJ
Device Description
The ACUSON S3000, S2000, S1000 Ultrasound Systems are a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. It is substantially equivalent to the S3000 system (K163635) and QLAB (K132165) which are legally marketed devices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, intra-cardiac, intra-luminal, breast, testes, thyroid, penis, prostate.
Indicated Patient Age Range
Adult and pediatric patients, Fetal, Neonatal, Pediatric.
Intended User / Care Setting
Physician, Clinician
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)
Nonclinical tests were submitted, including evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards. The system complies with AIUM/NEMA UD-3, AIUM/NEMA UD-2, IEC 62359, UL/IEC 60601-1, AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37, and ISO 10993-1. Clinical data was not required as the device uses the same technology and principles as existing devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 16, 2017
SIEMENS HEALTHCARE C/O Mr. MARK JOB Responsible Third Party Official 1394 25TH STREET, NW BUFFALO MN 55313
Re: K172162
Trade/Device Name: Acuson S2000 S2000 S1000 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: July 10, 2017 Received: July 18, 2017
Dear Mr. Job:
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 (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) 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara For
Robert Ochs Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172162
Device Name
ACUSON S3000™, S2000™, S1000™ Diagnostic Ultrasound System
Indications for Use (Describe)
The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, small organ, neonatal cephalic, adult cephalic, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography: Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The ACUSON AcuNav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatic patients.
The Transducer Indications for Use are on the attached pages.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED
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3
1.3 Indications for Use Forms
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use: ACUSON S3000, S2000, S1000 Diagnostic Ultrasound Systems
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | P | P | P | P | P | P | ||||
| Fetal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11, 12 | ||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,7,8,10, 11, | ||
| 13, 16,18,20 | ||||||||||
| Intraoperative | ||||||||||
| (Note 9) | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11, 14 | ||
| Intraoperative | ||||||||||
| Neurological | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11, 14 | ||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6, 7,8,10, 11 | ||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6, 7,8,10, | ||
| 11,14, 16,18,19,20 | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | ||
| Adult Cephalic | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | ||
| Cardiac | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10,15 | ||
| Trans-esophageal | P | P | P | P | P | P | BMDC | Note 4 | ||
| Transrectal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6, 7,8,10, | ||
| 11,14 | ||||||||||
| Transvaginal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11 | ||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note2,3,4,5,7,8,10, | ||
| 11,14,15 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11,14 | ||
| Musculo-skeletal | ||||||||||
| Superficial | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11,14 | ||
| Other (specify) | P | P | P | P | P | P | BMDC | Note 3,4,10,17 |
N = new indication; P = previously cleared by K162243; K130739 (VTI); K131164(VTQ); K130881 (VTIQ)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
-
Note 3 SieClear multi-view spatial compounding
-
Note 5 3-Scape real-time 3D imaging
-
B&W SieScape panoramic imaging Note 7
-
For example: vascular, abdominal Note 9
-
Note 11 Advanced Sieclear spatial compounding
-
eSie™ Touch elasticity imaging / FTI Note 14
-
Note 16 Custom Tissue Imaging VTI
-
Note 18
-
Note 6 Cadence contrast agent imaging Power SieScape panoramic imaging Note 8 Note 10 Clarify VE technology Note 13 STIC Note 15 AHP
Ensemble tissue harmonic imaqing
Tissue Equalization Technology
- Note 17 eSie Fusion
- Note 19 VTIQ
Note 2
Note 4
Note 20 VTQ
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office of In Vitro Diagnostic Devices
| 510(k) | |
|---|---|
| -------- | -- |
4
510 (k) Number (if known):
| Device Name: | CW2 Probe | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Mode of Operation | |||||||||||
| 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 9) | P | ||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | P | ||||||||||
| Small Organ | |||||||||||
| (Note 1) | P | ||||||||||
| Neonatal Cephalic | P | ||||||||||
| Adult Cephalic | P | ||||||||||
| Cardiac | P | ||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | P | ||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | P | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 9 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_
5
510 (k) Number (if known):
| Device Name: | CW5 Probe | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Mode of Operation | |||||||||||
| 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 9) | P | ||||||||||
| Intraoperative | |||||||||||
| Neurological | P | ||||||||||
| Pediatric | P | ||||||||||
| Small Organ | |||||||||||
| (Note 1) | P | ||||||||||
| Neonatal Cephalic | P | ||||||||||
| Adult Cephalic | P | ||||||||||
| Cardiac | P | ||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | P | ||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | P | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 9 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
| Division Sign-Off - Office of In Vitro Diagnostic Devices |
|---|
| 510(k) |
6
510 (k) Number (if known):
| Device Name:
Intended Use: | EC9-4 Curved Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|----------------------------------|----------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------------------|--|
| | | | | | | | Mode of Operation | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 | |
| Abdominal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11,
17 | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Note 1) | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11,14 | |
| Neonatal Cephalic | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5, 6, 7,8,10,
11,14 | |
| Transvaginal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 17 eSie™ Fusion
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)
7
510 (k) Number (if known):
| Device Name: | 9L4 Linear Array Transducer | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11 | ||||
| Abdominal | P | P | P | P | P | BMDC | Note 6,18,20 – any others? | ||||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,6, 7,8,10, 11 | ||||
| Small Organ | |||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,6,7,8,10, 11,14, | ||||
| 16,18,19,20 | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11 | ||||
| Adult Cephalic | P | P | P | P | P | ||||||
| Cardiac | P | P | P | P | P | BMDC | Note 15 | ||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5, 7,8,10, 11, | ||||
| 14,15 | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11, 14 | ||||
| Musculo-skeletal | |||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11, 14 | ||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
- Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Note 3 SieClear multi-view spatial compounding
- 3-Scape real-time 3D imaging Note 5
- Note 7 B&W SieScape panoramic imaging
- Note 10 Clarify VE vascular enhancement technology
- Note 14 eSie™ Touch elasticity imaging / FTI
- Note 16 Custom Tissue Imaging
- Note 19 VTIQ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 2
Note 4
Note 6
Note 8
Note 15 AHP
Note 18 VTI
Note 20 VTQ
Note 11 Advanced Sieclear
Ensemble tissue harmonic imaging
Power SieScape panoramic imaging
Tissue Equalization Technology
Cadence contrast agent imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office of In Vitro Diagnostic Devices
8
510 (k) Number (if known):
Device Name: Intended Use:
14L5BV Multi-D Array Transducer for use on S2000
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11, 14, 16 | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K081148
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Division Sign-Off - Office of In Vitro Diagnostic Devices
9
510 (k) Number (if known):
| Device Name:
Intended Use: | | 4P1 Phased Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|-------------------|--------------------------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|--|
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 | |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 | |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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| Division Sign-Off - Office of In Vitro Diagnostic Devices |
|---|
| 510(k) |
10
510 (k) Number (if known):
| Device Name: | 6C2 Curved Array Transducer | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11 | |||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11, 14, 16, 17 | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11 | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11 | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Tissue Equalization Technology Note 4
B&W SieScape panoramic imaging Note 7
Note 10 Clarify VE vascular enhancement technology
Note 14 eSie™ Touch elasticity imaging / FTI
Note 17 eSie Fusion
Note 3 SieClear multi-view spatial compounding
3-Scape real-time 3D imaging Note 5
Power SieScape panoramic imaging Note 8
Note 11 Advanced Sieclear spatial compounding
Note 16 Custom Tissue Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Division Sign-Off - Office of In Vitro Diagnostic Devices
11
510 (k) Number (if known):
| Device Name: | 4C1 Curved Array Transducer | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Mode of Operation | ||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |
| 11,18,19,20 | ||||||||||
| Abdominal | P | P | P | P | P | P | P | BMDC | Note2,3,4,5,6,7,8, | |
| 10, 11, 14, 16, 17 | ||||||||||
| Intraoperative | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P | Note 6 - others? | ||
| Small Organ | P | P | P | P | P | P | P | BMDC | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | P | BMDC | ||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | P | BMDC | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
- Note 2 Ensemble tissue harmonic imaging
- Note 4 Tissue Equalization Technology
- Note 6 Cadence contrast agent imaging
- Power SieScape panoramic imaging Note 8
- Note 11 Advanced Sieclear spatial compounding
- Note 16 Custom Tissue Imaging
- Note 18 VTI
- Note 20 VTQ
- Note 3 SieClear multi-view spatial compounding
- 3-Scape real-time 3D imaging Note 5
- Note 7 B&W SieScape panoramic imaging
- Note 10 Clarify VE vascular enhancement technology
- Note 14 eSie™ Touch elasticity imaging / FTI
- Note 17 eSie Fusion
- Note 19 VTIQ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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12
510 (k) Number (if known):
| Device Name:
Intended Use: | 6C1HD Curved Array Transducer HD
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------------------------------------|--|
| | | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11 | |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note2,3,4,5,6,7,8,
10,11,14,16,17,18,1
9,20 | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 6 – others? | |
| Small Organ | | P | P | P | P | P | P | | BMDC | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | BMDC | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
- Note 2 Ensemble tissue harmonic imaging
- Tissue Equalization Technology Note 4
Cadence contrast agent imaging Note 6
- Note 8 Power SieScape panoramic imaging
- Note 11 Advanced Sieclear spatial compounding
- Note 16 Custom Tissue Imaging
Note 20 VTQ
Note 3 SieClear multi-view spatial compounding
3-Scape real-time 3D imaging Note 5
Note 7 B&W SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 14 eSie™ Touch elasticity imaging / FTI
eSie Fusion Note 17 Note 19 VTIQ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)
Note 18 VTI
13
510 (k) Number (if known):
| Device Name:
Intended Use: | 8C3HD Curved Array Transducer for use with ACUSON S3000
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------------|--|
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11 | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11, 14, 16 | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11 | |
| Small Organ | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K#121138, K162243
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
- Note 3 SieClear multi-view spatial compounding
- Note 4 Tissue Equalization Technology
- 3-Scape real-time 3D imaging Note 5
- Cadence contrast agent imaging Note 6
- Note 7 B&W SieScape panoramic imaging
- Note 8 Power SieScape panoramic imaging
- Note 10 Clarify VE vascular enhancement technology
- Note 11 Advanced Sieclear spatial compounding
- Note 14 eSie™ Touch elasticity imaging / FTI
- Note 16 Custom Tissue Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office of In Vitro Diagnostic Devices
14
510 (k) Number (if known):
| Device Name: | 4V1 Phased Array Transducer | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Mode of Operation | ||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 14,16,17,18,19,20 | ||||||||||
| Intraoperative | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
-
Note 2 Ensemble tissue harmonic imaging
-
Tissue Equalization Technology Note 4
-
Note 7 B&W SieScape panoramic imaqinq
-
Note 10 Clarify VE vascular enhancement technology
-
Note 14 eSie™ Touch elasticity imaging / FTI
-
Note 17 eSie Fusion
-
Note 19 VTIQ
-
Note 3 SieClear multi view spatial compounding
3-Scape real-time 3D imaging Note 5 -
Power SieScape panoramic imaqing Note 8
-
Note 11 Advanced Sieclear spatial compounding
-
Note 16 Custom Tissue Imaging
-
Note 18 VTI
-
Note 20 VTQ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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15
510 (k) Number (if known):
| Device Name:
Intended Use: | 10V4 Phased Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|---------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Abdominal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Intraoperative | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | | BMDC | Note 3,4 |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
SieClear multi view spatial compounding Note 3
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Division Sign-Off - Office of In Vitro Diagnostic Devices
| 510(k) | |
|---|---|
| -------- | -- |
16
510 (k) Number (if known):
| Device Name: | 14L5 SP Linear Array Transducer | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Indications For Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| (Note 9) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | ||||
| Intraoperative | |||||||||||
| Neurological | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11 | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11,14, 16 | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | BMDC | Note 15 | ||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note2,3,4,5,7,8,10, | ||||
| 11,14,15 | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11,14 | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
For example: vascular, abdominal Note 9
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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510(k)
Note 15 AHP
Note 16 Custom Tissue Imaging
Note 15 AHP
Note 16 Custom Tissue Imaging
17
510 (k) Number (if known):
| Device Name: | 7CF2 Curved array mechanical 3D transducer | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Mode of Operation | ||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11,13 | ||||||||||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11, 13 | ||||||||||
| Intraoperative | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 13 STIC
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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18
510 (k) Number (if known):
Device Name:
9EVF4 Curved Array Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8, | ||
| 10,11, 13 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8, | |||
| 10,11 | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8, | |||
| 10,11 | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 13 STIC
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19
510 (k) Number (if known):
| Device Name:
Intended Use: | V5Ms Multiplane TEE Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| | | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | P | P | P | P | P | P | | BMDC | Note 4 | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Tissue Equalization Technology Note 4
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510(k)________________________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
20
510 (k) Number (if known):
| Device Name:
Intended Use: | 18L6 HD Linear Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------------------|
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11,14, 16 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | | P | P | | BMDC | Note 15 |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11,14,15 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11,14 |
| Musculo-skeletal
Superficial | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11,14 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaqinq
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
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510(k)
Note 15 AHP
Note 16 Custom Tissue Imaging
21
510 (k) Number (if known):
8V3 Phased Array Transducer
Device Name: Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | ||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | ||
| Small Organ | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | ||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | BMDC | Note 3,4 | ||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) | ||||||||||
| Neonatal Cardiac | P | P | P | P | P | P | BMDC | Note 3,4 |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 2 Ensemble tissue harmonic imaqing
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
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22
510 (k) Number (if known):
| Device Name: | 4V1c Phased Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|--------------|---------------------------------------------------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|---------------------------|-----------------------|---------------------------|
| | Intended Use: | | | | | | | Mode of Operation | | | |
| | Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| | Ophthalmic | | | | | | | | | | |
| | Fetal | | P | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 |
| | Abdominal | | P | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 |
| | Intraoperative | | P | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 |
| | Intraoperative
Neurological | | P | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 |
| | Pediatric | | P | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 |
| | Small Organ | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | |
| | Adult Cephalic | | P | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 |
| | Cardiac | | P | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10
15 |
| | Trans-esophageal | | | | | | | | | | |
| | Transrectal | | | | | | | | | | |
| | Transvaginal | | | | | | | | | | |
| | Transurethral | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| | Peripheral vessel | | P | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10
15 |
| | Laparoscopic | | | | | | | | | | |
| | Musculo-skeletal
Conventional | | | | | | | | | | |
| | Musculo-skeletal
Superficial | | | | | | | | | | |
| | Other (specify)
Neonatal Cardiac | | P | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Ensemble tissue harmonic imaging Note 2
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaqinq
Note 10 Clarify VE vascular enhancement technology
Note 15 AHP
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510 (k) Number (if known):
| Device Name: | EV8C4 Transducer | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Mode of Operation | ||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | ||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2 3 4 5 6 7 8 | ||
| 10 | ||||||||||
| Intraoperative | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | ||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 2 Ensemble tissue harmonic imaqing
Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
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24
510 (k) Number (if known):
| Device Name: | V7M TEE Transducer |
|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) * | Harmonic
Imaging | Other
(Specify) |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|---------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | P | P | Note 4 |
| Intraoperative | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P | P | Note 4 |
| Small Organ
(specify)** | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P | P | Note 4 |
| Trans-esophageal | | P | P | P | P | P | P | | P | P | Note 4 |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler,
B+M+POWER DOPPLER, B+PWD+POWER DOPPLER, B+CWD+POWER DOPPLER, B+CLARIFY VE
Note 2 Ensemble tissue harmonic imaging
- Tissue Equalization Technology Note 4
Note 10 Clarify VE vascular enhancement technology
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510 (k) Number (if known):
Device Name: Intended Use:
AcuNav 8F Ultrasound Catheter
›uCatheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Power | ||||||||||
| (Amplitude) | |||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) * | Other: | ||||||||||
| Harmonic | |||||||||||
| Imaging | |||||||||||
| Ophtalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| (Neurological) | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | |||
| Small Organ | |||||||||||
| (Specify)** | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P | P | |||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intra-Luminal | P | P | P | P | P | P | P | P | |||
| Peripheral Vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (Intra-Cardiac) | P | P | P | P | P | P | P | P |
P=Previously cleared by the FDA K162243
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler,
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510 (k) Number (if known):
Device Name: Intended Use:
AcuNav 10F Ultrasound Catheter
uCatheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) * | Other: Harmonic Imaging |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophtalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Intraoperative | ||||||||||
| (Neurological) | ||||||||||
| Pediatric | P | P | P | P | P | P | P | |||
| Small Organ | ||||||||||
| (Specify)** | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | P | |||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intra-Luminal | P | P | P | P | P | P | P | |||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (Intra-Cardiac) | P | P | P | P | P | P | P |
P=Previously cleared by the FDA K162243
Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler,
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510 (k) Number (if known): Device Name: Intended Use:
MC9-4 Transducer
Ultrasound 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 | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,11 |
| Abdominal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,11 |
| Intraoperative | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (note
-
| P | P | P | P | | P | P | | BMDC | Note
2,3,4,5,7,8,10,11,14 |
| Neonatal Cephalic | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | P | P | P | P | | P | P | | BMDC | Note
2,3,4,5,7,8,10,11,14 |
| Transvaginal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,11 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
i.e.: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 3 SieClear multi-view spatial compounding
Note 5 Siescape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 10 Clarify VE Vascular enhancement technology
Note 14 eSie Touch elasticity imaging/FTI
- Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 11 Advanced Sieclear spatial compounding
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510 (k) Number (if known): Device Name: Intended Use:
14L5 Transducer Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (note |
-
| | P | P | P | | P | P | | BMDC | Note
2,3,4,5,7,8,10,11,14,
16 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note
2,3,4,5,6,7,8,10,11,1
4 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note
2,3,4,5,7,8,10,11,14 |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc.
SieClear multi-view spatial compounding Note 3
Siescape real-time 3D imaging Note 5
Note 7 B&W SieScape panoramic imaqinq
Note 10 Clarify VE Vascular enhancement technology
Note 14 eSie Touch elasticity imaging/FTI
- Note 2 For example: vascular, abdominal
Tissue Equalization Technology Note 4
Cadence contrast agent imaging Note 6
Note 8 Power SieScape panoramic imaqing
Advanced Sieclear spatial compounding Note 11
Note 16 Custom Tissue Imaging
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Division Sign-Off - Office of In Vitro Diagnostic Devices
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510(k) Summary Prepared April 24, 2017
| 1. Sponsor: | Siemens Medical Solutions USA, Inc., |
|---|---|
| Contact Person: | Ultrasound Division |
| 685 East Middlefield Road | |
| Mountain View, California 94043 | |
| Shelly Pearce | |
| Telephone: (650)279-0134 | |
| 2. Device Name: | ACUSON S3000™, S2000™, S1000™ Diagnostic Ultrasound Systems |
| Common Name: | Diagnostic Ultrasound System |
| Classification: | |
| Regulatory Class: | II |
| Review Category: | Tier II |
| Classification Panel: | Radiology |
| Ultrasonic Pulsed Doppler Imaging System | FR # 892.1550 | Product Code 90-IYM |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging System | FR # 892.1560 | Product Code 90-IYC |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX |
| Diagnostic Ultrasound Catheter | FR # 870.1200 | Product Code OBJ |
3. Leqally Marketed Predicate Devices
The modified ACUSON S3000™, S2000™, S1000™, S1000™ Ultrasound Systems is substantially equivalent to the company's own S3000 Ultrasound System (K163635) and Philips QLAB (K0132165).
4. Device Description:
The ACUSON S3000, S2000, S1000 Ultrasound Systems are a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. It is substantially equivalent to the S3000 system (K163635) and QLAB (K132165) which are legally marketed devices.
Image /page/29/Picture/8 description: The image shows the word "SIEMENS" in a teal color. The font is bold and sans-serif. The letters are evenly spaced and the word is centered.
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5. Intended Use
The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, transesophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The AcuNav Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.
| Feature / Characteristic | Acuson
S3000,
S2000,
S1000 | Acuson
S3000,S2000
, S1000
K163635 | QLAB
K132165 | |
|-----------------------------------------------|-------------------------------------------------|---------------------------------------------|---------------------------------------------|-----------------|
| Indications for Use: | | | | |
| ■ Fetal | √ | √ | | |
| ■ Abdominal | √ | √ | | |
| ■ Intraoperative abdominal and
vascular | √ | √ | | |
| ■ Intraoperative neurological | -- | -- | | |
| ■ Pediatric | √ | √ | | |
| ■ Small Organ | √ | √ | | |
| ■ Neonatal cephalic | √ | √ | | |
| ■ Adult Cephalic | √ | √ | | |
| ■ Cardiac | √ | √ | | |
| ■ Trans-esophageal | √ | √ | | |
| ■ Transrectal | √ | √ | | |
| ■ Transvaginal | √ | √ | | |
| ■ Peripheral vessel | √ | √ | | |
| | Feature / Characteristic | Acuson
S3000,
S2000,
S1000 | Acuson
S3000,S2000
, S1000
K163635 | QLAB
K132165 |
| ■ | Laparoscopic | -- | -- | |
| ■ | Musculo-skeletal (conventional) | √ | √ | |
| ■ | Musculo-skeletal (superficial) | √ | √ | |
| | Center Frequencies Supported: | | | |
| ■ | 2.0 MHz | √ | √ | |
| ■ | 3.0 MHz | √ | √ | |
| ■ | 3.2 MHz | √ | √ | |
| ■ | 3.3 MHz | √ | √ | |
| ■ | 4.2 MHz | √ | √ | |
| ■ | 4.4 MHz | √ | √ | |
| ■ | 4.8 MHz | √ | √ | |
| ■ | 5.0 MHz | √ | √ | |
| ■ | 5.2 MHz | √ | √ | |
| ■ | 6.0 MHz | √ | √ | |
| ■ | 6.5 MHz | √ | √ | |
| ■ | 6.9 MHz | √ | √ | |
| ■ | 9.5 MHz | √ | √ | |
| ■ | 10.0 MHz | √ | √ | |
| | Modes: | | | |
| ■ | B | √ | √ | |
| ■ | Parallel processing in B mode | √ | √ | |
| ■ | M | √ | √ | |
| ■ | PWD (Pulsed Wave Doppler) | √ | √ | |
| ■ | CWD (Continuous Wave Doppler) | √ | √ | |
| ■ | D (Color Doppler) | √ | √ | |
| ■ | Amplitude Doppler | √ | √ | |
| ■ | Combined (BMDC) | √ | √ | |
| | Features: | | | |
| ■ | Quad processing in color | √ | √ | |
| ■ | Native™ tissue harmonic imaging | √ | √ | |
| ■ | SieScape™ panoramic imaging | √ | √ | |
| ■ | Color SieScape™ panoramic imaging | √ | √ | |
| ■ | 3-Scape™ real-time 3D imaging | √ | √ | |
| ■ | fourSight™ 4D transducer
technology | √ | √ | |
| ■ | TEQ™ ultrasound technology | √ | √ | |
| ■ | Cardiac Imaging
physiological signal display | √ | √ | |
| ■ | syngo ® Auto OB measurements | √ | √ | |
| ■ | Advanced SieClear™ spatial
compounding | √ | √ | |
| ■ | STIC (Fetal Heart Imaging) | √ | √ | |
| ■ | Amnioscopic rendering | √ | √ | |
| ■ | Cadence contrast agent imaging | √ | √ | |
| Feature / Characteristic | Acuson
S3000,
S2000,
S1000 | Acuson
S3000,S2000
, S1000
K163635 | QLAB
K132165 | |
| ■ Contrast Dynamics | √ | | √ | |
| ■ Clarify™ vascular enhancement
technology | √ | √ | | |
| ■ eSie™ Touch elasticity imaging | √ | √ | | |
| ■ syngo ® Auto Left heart | Tested to ISO
10993-1 | √ | | |
| ■ syngo ® Velocity Vector Imaging | √ | √ | | |
| ■ Semi Auto-segmentation (eSie
Calc) | √ | √ | | |
| ■ Custom Tissue Imaging / Speed of
Sound | √ | √ | | |
| ■ VTI (S2000, S3000) | √ | √ | | |
| ■ VTIQ (S2000, S3000) | √ | √ | | |
| ■ VTQ (S2000, S3000) | √ | √ | | |
| ■ AHP | √ | √ | | |
| ■ Monitor: 19" FPD | √ | √ | | |
| ■ eSie Fusion | √ | √ | | |
| Output Display Standard (Track 3) | √ | √ | | |
| Patient Contact Materials | Tested to ISO
10993-1 | Tested to ISO
10993-1 | | |
| UL 60601-1 Certified | √ | √ | | |
| Indications for Use | | √ | | |
6. Summary of Technological Characteristics - New Device Compared to Predicate
Image /page/30/Picture/8 description: The image shows the word "SIEMENS" in a teal, sans-serif font. The letters are bold and evenly spaced. The background is white, providing a clean contrast that makes the brand name stand out.
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Siemens Medical Solutions USA, Ultrasound Division ACUSON S3000™, S2000™, S1000™ Ultrasound Systems 510(k)
Image /page/31/Picture/2 description: The image shows the word "SIEMENS" in a teal, sans-serif font. The letters are bold and evenly spaced. The background is plain white, which makes the word stand out.
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Siemens Medical Solutions USA, Ultrasound Division ACUSON S3000™, S2000™, S1000™ Ultrasound Systems 510(k)
7. 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, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:
- I AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- I AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 트 IEC 62359, Test methods for the determination of thermal and mechanical indices
- Safety and EMC Requirements for Medical Equipment I
- o UL/IEC 60601-1
- o AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012
- o IEC 60601-1-2
- o IEC 60601-2-18
- o IEC 60601-2-37
- ISO 10993-1 Biocompatibility I
Image /page/32/Picture/14 description: The image shows the word "SIEMENS" in all capital letters. The text is a teal color. The font is sans-serif and appears to be bolded.
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Cleared patient contact materials, electrical and mechanical safety are unchanged. Testing was performed to verify the software release.
8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Since the ACUSON S3000, S2000, S1000 Ultrasound Systems use the same technology and principles as existing devices, clinical data is not required.
9. Summarv
Intended uses and other key features are consistent with traditional clinical practice and FDA quidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the ACUSON S3000. S2000. S1000 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
Image /page/33/Picture/6 description: The image shows the word "SIEMENS" in a bold, teal-colored font. The letters are all capitalized and evenly spaced. The background is plain white, which makes the word stand out.