(14 days)
K121138, 122825
No
The document does not mention AI, ML, or related terms, and the device description focuses on standard ultrasound imaging modes and measurement packages.
No.
The device description and intended use clearly state that it is a diagnostic ultrasound system intended for imaging and measurement, not for therapeutic purposes.
Yes
The 'Device Description' specifically states: "The S1000™ Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system..." Furthermore, the 'Intended Use / Indications for Use' section mentions 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" and supports packages like the Arterial Health Package (AHP) for assessment of the cardiovascular system.
No
The device description explicitly states it is a "multi-purpose mobile, software controlled diagnostic ultrasound system," indicating it includes hardware components for acquiring and displaying ultrasound data, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The S1000™ ultrasound imaging system is a diagnostic imaging device that uses ultrasound waves to create images of internal anatomical structures. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes imaging applications and measurements of anatomical structures. While the information obtained can be used adjunctively with other medical data for clinical diagnosis, the device itself is not performing an in vitro test.
- Device Description: The description focuses on the technical aspects of ultrasound imaging and display modes.
- Lack of IVD-related information: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, the S1000™ ultrasound imaging system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The S1000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, 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, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 Ultrsound 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 pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX, OBJ
Device Description
The S1000™ Ultrasound System is 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 (K122825) which is a legally marketed device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Intraoperative, Pediatric, Small Parts (e.g. breast, testes, thyroid, penis, prostate), Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intra-cardiac, Intra-luminal, Great vessel
Indicated Patient Age Range
Adult and pediatric patients, Neonatal
Intended User / Care Setting
Physician / Clinical setting
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)
Since the S1000 uses the same technology and principles as existing devices, clinical data is not required. The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards: UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2, IEC 1157 Declaration of Acoustic Power, ISO 10993-1 Biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K121138, 122825
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
K130619
Page 1 of 4
510(k) Summarv Prepared February 4, 2013
MAR 2 1 2013
510(k) Submission
| 1. Sponsor: | Siemens Medical Solutions, Inc.,
Ultrasound Division |
|-------------|--------------------------------------------------------------|
| | 685 East Middlefield Road
Mountain View, California 94043 |
| Contact Person: | Shelly Pearce | |
|---|---|---|
| Telephone: | (650) 694-5988 | |
| Fax: | (650) 694-5580 |
-
- Device Name: Acuson S1000™ Diagnostic Ultrasound System
- Common Name: Diagnostic Ultrasound System
Classification:
Regulatory Class: ll Tier II Review Category: Classification Panel: Radiology
| Ultrasonic Pulsed Doppler Imaging System | FR # 892.1550 | Product Code 90-IYN |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging System | FR # 892.1560 | Product Code 90-IYO |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX |
| Diagnostic Ultrasound Catheter | FR # 870.1200 | Product Code OBJ |
3. Legally Marketed Predicate Devices
The Acuson S1000™Ultrasound System is substantially equivalent to the company's own S3000 Ultrasound System (K122825).
4. Device Description:
The S1000™ Ultrasound System is 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 (K122825) which is a legally marketed device.
5. Intended Use
The $1000™ ultrasound imaging systems are intended for the following applications: Fetal. Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
ーーーーーーーーーーーーーーーーーーーー
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult
1
S1000 Ultrasound System
510(k) Submission
cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adiunctively 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 Ultrsound 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 pediatric patients.
6. Summary of Technological Characteristics - New Device Compared to Predicate
| | Feature / Characteristic | Acuson
S1000 | Acuson
S3000
K122825 |
|-----------------------------------|-------------------------------------------------|----------------------------|----------------------------|
| | 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 | -- | -- |
| ■ | 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 | √ | √ |
| | Feature / Characteristic | Acuson S1000 | Acuson S3000
K122825 |
| | 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 | √ | √ |
| | Clarify™ vascular enhancement
technology | √ | √ |
| | eSie™ Touch elasticity imaging | √ | √ |
| | eSie Fusion | √ | √ |
| | syngo ® Auto Left heart | √ | √ |
| | syngo ® Velocity Vector Imaging | √ | √ |
| | Semi Auto-segmentation (eSie
Calc) | √ | √ |
| | Custom Tissue Imaging / Speed of
Sound | √ | √ |
| | AHP | √ | √ |
| Feature / Characteristic | Acuson
S1000 | Acuson
S3000
K122825 | |
| 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 | √ | √ | |
2
.
S1000 Ultrasound System 510(k) Submission
3
K130619
page 4 of 4
S1000 Ultrasound System 510(k) Submission
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, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:
- UL 60601-1, Safety Requirements for Medical Equipment ■
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards ■
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment ■
- 해 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 ■
- 트 93/42/EEC Medical Devices Directive
- l Safety and EMC Requirements for Medical Equipment
- EN/IEC 60601-1 .
- . EN/IEC 60601-1-1
- s EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power ●
- ISO 10993-1 Biocompatibility D
Cleared patient contact materials, electrical and mechanical safety are unchanged.
8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Since the $1000 uses the same technology and princibles as existing devices. clinical data is not required.
9. Summary
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 S1000 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three overlapping, curved lines forming its body and wings.
Public Health Service
Food and Drup Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2013
Siemens Medical Solutions, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K130619
Trade/Device Name: S1000" 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 and OBJ Dated: March 6, 2013 Received: March 7, 2013
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.
This determination of substantial equivalence applies to the following transducers intended for use with the S.1000 Diagnostic Pulsed Doppler Imaging System, as described in your premarket notification:
Transducer Model Numbers
| CW2 | 14L5 | 14L5SP | AcuNav 10F |
|---|---|---|---|
| CW5 | 4P1 | 9EVF4 | V7M |
| 4C1 | V5Ms | 7CF2 | 6C1HD |
| EC9-4 | 6C2 | 4V1c | 6L3 |
| 9L4 | 4V1 | EV8C4 | |
| 8V3 | 10V4 | AcuNav 8F |
5
Page 2 - Mr. Mark Job
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,
Smh7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
1.3 Indications for Use
A. 510(k) Number (if known):
Device Name: S1000™Diagnostic Ultrasound System
Indications for Use:
The S1000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, 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, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac) and calculation packages that provide information 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 Ultrsound 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 pediatric patients.
Prescription Use × (Part 21CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
7
1.3 Indications for Use Forms
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
ACUSON S1000 Ultrasound System
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 | N | N | N | N | N | N | N | BMDC | ||
| Fetal | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | |
| 11, 13 | ||||||||||
| Abdominal | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | |
| 11, 13, 16 | ||||||||||
| Intraoperative | ||||||||||
| (Note 9) | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | |
| 11, 14 | ||||||||||
| Intraoperative | ||||||||||
| Neurological | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | |
| 11, 14 | ||||||||||
| Pediatric | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | |
| 11 | ||||||||||
| Small Organ | ||||||||||
| (Note 1) | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | |
| 11,14, 16 | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10 | |
| Adult Cephalic | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10 | |
| Cardiac | N | N | N | N | N | N | N | BMDC | Note | |
| 2,3,4,5,6,7,8,10,15 | ||||||||||
| Trans-esophageal | N | N | N | N | N | N | N | BMDC | Note 4 | |
| Transrectal | N | N | N | N | N | N | N | BMDC | Note 2,3,4.5,7,8,10, | |
| 11,14 | ||||||||||
| Transvaginal | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | |
| 11 | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | N | N | N | N | N | N | N | BMDC | Note2,3,4,5,6,7,8,10, | |
| 11,14,15 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | |
| 11,14 | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | |
| 11,14 | ||||||||||
| Other (specify) | ||||||||||
| Neonatal Cardiac | N | N | N | N | N | N | N | BMDC | Note 3,4,6, 10 |
N = new indication; P = previously cleared by FDA K121138, 122825
Note 1 For example: breast, testes, thyroid, penis, prostate, etc
SieClear multi-view spatial compounding Note 3
3-Scape real-time 3D imaging Note 5 Note 7
B&W SieScape panoramic imaging Note 9 For example: vascular, abdominal
Note 11 Advanced Sieclear spatial compounding
eSie™ Touch elasticity imaging / FTI Note 14
Note 16 Custom Tissue Imaging Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clanfy VE vascular enhancement technology
- Note 13 STIC
Note 15 AHP
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
8
510 (k) Number (if known):
| Device Name: | CW2 Probe for use with ACUSON S1000 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 K# 121138, 122825
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1 Note 9 For example: vascular, abdominal
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
9
510 (k) Number (if known):
Device Name: Intended Use:
CW5 Probe for use with ACUSON S1000
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 K# 121138, 122825
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 9 For example: vascular, abdominal
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 210(K)
10
510 (k) Number (if known):
Device Name:
Intended Use:
EC9-4 Curved Array Transducer for use with ACUSON S1000 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 2,3,4,5,6,.7,8,10, 11. | ||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11,14 | ||||
| Neonatal Cephalic | 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 | BMDC | Note 2,3,4,5,6,7,8,10, | ||||
| 11,14 | |||||||||||
| 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 K# 121138, 122825
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
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
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
11
510 (k) Number (if known):
Device Name: Intended Use:
9L4 Linear Array Transducer for use with ACUSON $1000 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 | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11 | ||||
| Small Organ | |||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,6,7,8,10, 11,14, | ||||
| 16 | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11 | ||||
| Adult Cephalic | P | P | P | P | P | BMDC | |||||
| Cardiac | P | P | P | P | P | BMDC | Note 15 | ||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,6,7,8,10, 11, | ||||
| 14,15 | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,6,7,8,10, 11, 14 | ||||
| Musculo-skeletal | |||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 2,3,4,5,6,7,8,10. 11, 14 | ||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 121138, 122825
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
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
eSie™ Touch elasticity imaging / FTI Note 14
Note 15 AHP
Note 16 Custom Tissue Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 210(k)
12
510 (k) Number (if known):
Device Name: Intended Use:
14L5 Multi-D Array Transducer for use with ACUSON S1000 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 | ||||||||||
| Abdominal | ||||||||||
| 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 | P | P | P | P | P | BMDC | Note 2.3,4,5,6, | |||
| 7,8,10, 11, 14 | ||||||||||
| 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 K# 121138, 122825
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
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 / FTJ
Custom Tissue Imaging Note 16
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
13
S1000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
4P1 Phased Array Transducer for use with ACUSON S1000 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 | ||||||||||
| Abdominal | ||||||||||
| 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 2,3,4,5,6,7,8,10 | ||
| 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 K# 121138, 122825
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
Cadence contrast agent imaging Note 6
B&W SieScape panoramic imaging Note 7
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
14
S1000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
| Device Name:
Intended Use: | 6C2 Curved Array Transducer for use with ACUSON S1000
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
Abdominal | | | | | | | | | | | |
| 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 K# 121138, 122825
Additional Comments:
- Ensemble tissue harmonic imaging Note 2
- Note 4 Tissue Equalization Technology
B&W SieScape panoramic imaging Note 7
Note 10 Clarify VE vascular enhancement technology
Note 14 eSie™ Touch elasticity imaging / FTI
- Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 8 Power SieScape panoramic imaging
Advanced Sieclear spatial compounding Note 11
Note 16 Custom Tissue Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
15
S1000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
| Device Name: | 4C1 Curved Array Transducer for use with ACUSON S1000 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||||||||
| Abdominal | P | P | P | P | P | P | BMDC | Note2,3,4,5,6,7,8, | ||||||
| 10, 11, 14, 16 | ||||||||||||||
| Intraoperative | ||||||||||||||
| Abdominal | ||||||||||||||
| Intraoperative | ||||||||||||||
| Neurological | ||||||||||||||
| Pediatric | ||||||||||||||
| 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 K# 121138, 122825
Additional Comments:
Ensemble tissue harmonic imaging Note 2
- Note 4 Tissue Equalization Technology
Cadence contrast agent imaging Note 6
Power SieScape panoramic imaging Note 8
Advanced Sieclear spatial compounding Note 11
- Note 16 Custom Tissue Imaging
- SieClear multi-view spatial compounding Note 3
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
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 210(K)
16
S1000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
| Device Name: | 6C1HD Curved Array Transducer for use with ACUSON S1000 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||||||||||
| Abdominal | P | P | P | P | P | P | BMDC | Note2.3,4,5.6.7,8. | |||
| 10, 11, 14, 16 | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| 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 K# 121138, 122825
Additional Comments:
- Ensemble tissue harmonic imaging Note 2
- Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
- Power SieScape panoramic imaging Note 8
Advanced Sieclear spatial compounding Note 11
Note 16 Custom Tissue Imaging
- Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape 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
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
17
S1000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
4V1 Phased Array Transducer for use with ACUSON S1000 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 | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethra! | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 121138. 122825
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Note 7 B&W SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 14 eSie™ Touch elasticity imaging / FTI
- Note 3 SieClear multi view spatial compounding
3-Scape real-time 3D imaging Note 5
Note 8 Power SieScape panoramic imaging
Note 11 Advanced Sieclear spatial compounding
Note 16 Custom Tissue Imaging
.
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) _
18
S1000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name:
Intended Use:
10V4 Phased Array Transducer for use with ACUSON S1000 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 | ||||||||||
| Abdominal | ||||||||||
| 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 | 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 K# 121138, 122825
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
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
19
S1000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Indications For Use:
14L5 SP Linear Array Transducer for use with ACUSON S1000 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 | Note 2,3,4,5,6, | ||||
| 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 K# 121138, 122825
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
Cadence contrast agent imaging Note 6
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
Note 9 For example: vascular, abdominal
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
S1000 510(k) Submission
Note 15 AHP
Note 16 Custom Tissue Imaging
Note 15 AHP
20
510 (k) Number (if known):
| Device Name: | 7CF2 Curved array mechanical 3D transducer for use with ACUSON S1000 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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, | |||
| 11,13 | ||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11, 13 | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| 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 K# 121138, 122825
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
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
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
21
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name:
Intended Use:
9EVF4 Curved Array Transducer for use with ACUSON S1000 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, 13 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| 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 K# 121138, 122825
Additional Comments:
Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
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
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
22
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
| Device Name: | V5Ms Multiplane TEE Transducer for use with ACUSON S1000 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| 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 K# 121138, 122825
Additional Comments:
Note 4 Tissue Equalization Technology
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
23
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use: 8V3 Phased Array Transducer for use with ACUSON S1000 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 | ||||||||||
| Abdominal | ||||||||||
| 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 3,4,6 | ||
| 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 3,4,6 |
N = new indication; P = previously cleared by FDA K#121138. 122825
Additional Comments:
. Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
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
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
24
S1000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
| Device Name:
Intended Use: | 4V1c Phased Array Transducer for use with ACUSON S1000
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
Abdominal | | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10 | |
| Intraoperative
Neurological | | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10 | |
| Pediatric | | 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 | | 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 | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | 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 | | BMDC | Note 2 3 4 5 7 8 10 | |
N = new indication; P = previously cleared by FDA K 121138. 122825
Additional Comments:
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
Cadence contrast agent imaging Note 6
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
Clarify VE vascular enhancement technology Note 10
Note 15 AHP
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health ર I 0(k)
25
S1000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
| Device Name: | 6L3 Transducer for use with ACUSON S1000 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | |||
| 11 | |||||||||||
| Intraoperative | |||||||||||
| Neurological | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | |||
| 11 | |||||||||||
| Pediatric | |||||||||||
| Small Organ | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | |||
| 1 | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | 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 | BMDC | Note 2 3 4 5 7 8 10, | |||
| 11 15 | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | |||
| 11 | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | |||
| 11 |
N = new indication; P = previously cleared by FDA K # 121138, 122825
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
Cadence contrast agent imaging Note 6
B&W SieScape panoramic imaging Note 7
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 15 AHP
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)________________________________________________________________________________________________________________________________________________________________________
26
510 (k) Number (if known):
Device Name:
Intended Use:
EV8C4 Transducer for use with ACUSON S1000 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 | |||||||||||
| Abdominal | |||||||||||
| 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 6 7 8 | |||
| 10 | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 121138, 122825
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
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
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
27
S1000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
V7M TEE Transducer for use with ACUSON S1000
Device Name: Intended Use: V7M TEE Transducer for use with ACUSON S1000 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
Abdominal | | | | | | | | | | | |
| 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) | | | | | | | | | | | |
P=previously cleared by the FDA under premarket notifications # K121138, 122825
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
- Note 4 Tissue Equalization Technology
Note 10 Clarify VE vascular enhancement technology
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
28
510 (k) Number (if known):
Device Name: Intended Use:
AcuNav 8F Ultrasound Catheter for use with ACUSON S1000 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.
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) * | Other:
Harmonic
Imaging | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|--|
| Ophtalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
(Vascular) | | | | | | | | | | | |
| 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 K121138, 122825
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
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) .
29
S1000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
AcuNav 10F Ultrasound Catheter for use with ACUSON S1000 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.
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) * | Other:
Harmonic
Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|
| Ophtalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
(Vascular) | | | | | | | | | | |
| 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 K121138, 122825
Additional Comments:
- Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppier, B+Power Doppler,
B+M+POWER DOPPLER, B+PWD+POWER DOPPLER, B+CWD+POWER DOPPLER
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 210(k) K130619