(55 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
No
The device is described as an "Ultrasound imaging or fluid flow analysis" system used for "clinical diagnosis purposes," and its product safety standards include "Diagnostic Ultrasound Safety Standards," indicating its role in diagnosis rather than treatment.
Yes
The device's "Intended Use / Indications for Use" explicitly states that the system provides "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." Additionally, the "Device Description" mentions "IEC 60601-2-37 Diagnostic Ultrasound Safety Standards" multiple times, directly linking the device to diagnostic purposes.
No
The device description explicitly mentions compliance with hardware safety standards (UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, etc.) and describes a "system" (Siemens Sequoia™ Plus), indicating it is a physical ultrasound machine with associated software, not software operating on general-purpose hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for "Ultrasound imaging or fluid flow analysis of the human body." This is a direct imaging modality applied to the patient's body.
- 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 Description: The device description focuses on safety standards related to medical equipment and diagnostic ultrasound, not laboratory testing or analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
The device is a diagnostic ultrasound system used for imaging the internal structures and fluid flow within the human body. While the information it provides can be used by a clinician for diagnosis, the device itself does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Sequoia Plus ultrasound imaging system is intended for the following applications: Cardiac, Neonatal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.
The system also provides the ability to measure anatomical structures 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 typical examinations performed using the Sequoia™ Plus Ultrasound System are:
Cardiac Imaging Applications and Analysis
The system transmits ultrasound energy into the thorax from the chest wall or trans-esophagueal into adult, pediatric, or neonatal patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Vascular Imaging Applications and Analysis
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs; and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Superficial Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
Intraoperative Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during neurological intraoperative procedures.
Transcranial Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology.
The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Product codes
90-IYN, 90-IYO, 90-ITX, IYN, IYO, ITX
Device Description
The Siemens Sequoia™ Plus has been designed to meet the following product safety 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
- 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
- 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment
- EN/IEC 60601-1
- EN/IEC 60601-1-1
- EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power
- ISO 10993-1 Biocompatibility
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, Neonatal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, Musculo-skeletal Superficial, thorax, heart, cardiac valves, great vessels, carotid arteries, jugular veins, arms, legs, musculoskeletal structures, brain
Indicated Patient Age Range
Adult, Pediatric, Neonatal.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Sequoia™ Plus is designed, verified, and validated according to the company's design control process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Siemens Acuson Sequoia Ultrasound System cleared under K063085, K051139.
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
4.2.13b 510(k) Summary/Statement Certification
510(k) Summary Prepared September 17, 2007
007 17 2007
| Sponsor: | Siemens Medical Solutions, Inc.,
Ultrasound Division
1230 Shorebird Way
Mountain View, California 94043 |
|------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Robert F. Lawrence
Telephone: (650) 943 5984
Fax: (650) 943 7053 |
| Submission Date: | September 17, 2007 |
| Device Name: | Sequoia™ Plus Ultrasound System |
| 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-IYN |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging System | FR # 892.1560 | Product Code 90-IYO |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX |
A. Legally Marketed Predicate Devices
The Siemens Sequoia™ Plus Ultrasound System is substantially equivalent to the Siemens Acuson Sequoia Ultrasound System.
B. Device Description:
The Siemens Sequoia™ Plus has been designed to meet the following product safety standards:
- 트 UL 60601-1, Safety Requirements for Medical Equipment
- 트 IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- . CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- 지 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
- 제 Safety and EMC Requirements for Medical Equipment
- . EN/IEC 60601-1
- a EN/IEC 60601-1-1
- . EN/IEC 60601-1-2
- . IEC 1157 Declaration of Acoustic Power
- K ISO 10993-1 Biocompatibility
1
C. Intended Use
The Sequoia Plus ultrasound imaging system is intended for the following applications: Cardiac, Neonatal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skelctal Conventional, and Musculo-skeletal Superficial applications.
The system also provides the ability to measure anatomical structures 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 typical examinations performed using the Sequoia™ Plus Ultrasound System are:
Cardiac Imaging Applications and Analysis
The system transmits ultrasound energy into the thorax from the chest wall or trans-esophagueal into adult, pediatric, or neonatal patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Vascular Imaging Applications and Analysis
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs; and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Superficial Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
Intraoperative Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during neurological intraoperative procedures.
Transcranial Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology.
The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
2
D. Substantial Equivalence
The submission device is substantially equivalent to the predicate Acuson Sequoia™ previously cleared under K063085 and K051139 with regard to both intended use and technological characteristics.
E. Performance Data
The Sequoia™ Plus is designed, verified, and validated according to the company's design control process.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2007
Siemens Medical Solutions, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K072365
Trade/Device Name: SequoiaTM Plus Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: August 22, 2007 Received: August 23, 2007
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Sequoia™ Plus Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
9L4 V5M TEE 4V1c AUX CW2 4Z1c
4
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
5
If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (240) 276-3666.
Sincerely yours,
Vorut M. Whang
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
6
| 510(k) Number (if known): | K072365 | |
|---|---|---|
| -- | --------------------------- | --------- |
Device Name:
Sequoia™ Plus Diagnostic Ultrasound System
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:
3D | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|--------------|------------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | | |
| Intraoperative
Neurological | | N | N | N | | N | N | | N* | N | | |
| Pediatric | | N | N | N | N | N | N | N | N* | N | N | N |
| Small Organ
(specify) | | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | N | N | N | N | N | N | N | N* | N | | |
| Cardiac | | N | N | N | N | N | N | N | N* | N | N | N |
| Trans-esophageal | | N | N | N | N | N | | | N* | | N | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vessel | | N | N | N | | N | N | N | N* | N | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | N | N | N | | N | N | N | N* | N | | |
| Musculo-skeletal
Superficial | | N | N | N | | N | N | N | N* | N | | |
| Other (specify) ** | | N | N | N | N | N | N | | N* | N | | |
N=new indication.
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 1000 - 100
**neonatal cardiac
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Norris K. Wong
(Division S Division of Reproductive. Abdominal and Radiological Device 510(k) Number
Sequoia™ Plus 510(k) Submission
PagePage 12 of 1739
7
| 510(k) Number (if known): | K072365 |
|---|---|
| Device Name: | 9L4 |
Indications for 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:
3D | Other:
Real
Time
3D | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|--------------|------------------------------|--|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | | | |
| Intraoperative
Neurological | | P | P | P | | P | P | P | P* | P | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ
(specify) | | | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | | P | P | P | P* | P | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | P | P* | P | | | |
| Musculo-skeletal
Superficial | | P | P | P | | P | P | P | P* | P | | | |
| Other (specify) | | | | | | | | | | | | | |
N=new indication
P= previously cleared by FDA
E= added under Appendix E
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
Previously Cleared in 510(k) K063085
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and
510(k) Numbe
Sequoia™ Plus 510(k) Submission
PagePage 13 of 1739
8
| 510(k) Number (if known): | K072365 |
|---|---|
| Device Name: | V5M TEE |
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: 3D | Other: Real Time 3D | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|-----------|---------------------|--|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | | | |
| 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 | | P | P | P | P | P | | | P* | | P | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | | |
N=new indication
P= previously cleared by FDA
510 k) Nu
E= added under Appendix E
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
Previously Cleared in 510(k) K063085, K022567
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices 1077365
Sequoia™ Plus 510(k) Submission
PagePage 14 of 1739
9
| 510(k) Number (if known): | K072365 |
|---|---|
| Device Name: | 4V1c |
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:
3D | Other:
Real
Time
3D | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|--------------|------------------------------|--|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P | | | |
| Small Organ
(specify) | | | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | P* | P | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P | | | |
| Trans-esophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | | |
| Other (specify)** | | P | P | P | P | P | P | | P* | P | | | |
N=new indication
P= previously cleared by FDA
E= added under Appendix E
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 | |
| **neonatal cardiac |
Previously Cleared in 510(k) K063085, K022567
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Amil Wh
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiolo 510(k) Nun
Sequoia™ Plus 510(k) Submission
PagePage 15 of 1739
10
| 510(k) Number (if known): | K072365 |
|---|---|
| Device Name: | AUX CW2 |
Intended Use:
Ultrasound 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:
3D | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|--------------|------------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | P | | | | | | |
| Small Organ
(specify) | | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | P | | | | | | |
| 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
E= added under Appendix E
Additional Comments: Previously Cleared in 510(k) K063085, K001400
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
_
(Division Sign-Off)
Sequoia™ Plus 510(k) Submission
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
PagePage 16 of 1739
11
| 510(k) Number (if known): | K072365 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device Name: | 4Z1c | |||||||||||
| 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: | |||||||||||
| 3D | Other: | |||||||||||
| Real | ||||||||||||
| Time | ||||||||||||
| 3D | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative | ||||||||||||
| Neurological | ||||||||||||
| Pediatric | P | P | P | P | P | p* | P | P | p | |||
| Small Organ | ||||||||||||
| (specify) | ||||||||||||
| Neonatal | ||||||||||||
| Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | P | P | P | P | P | P* | P | P | P | |||
| Trans-esophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vessel | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Conventional | ||||||||||||
| Musculo-skeletai | ||||||||||||
| Superficial | ||||||||||||
| Other (specify) |
N=new indication
P= previously cleared by FDA
Division
E= added under Appendix E
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
Previously Cleared in 510(k) K051139
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Aomi M. Wils
Sequoia™ Plus 510(k) Submission
oductive. Abdominal and Division of Radiol 510(k) N
PagePage 17 of 1739