(86 days)
The SonoScape S2 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
The SonoScapeS2 Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D.
This document details the acceptance criteria for the SonoScape S2 Portable Digital Color Doppler Ultrasound System and the study supporting its compliance.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against recognized medical device safety standards and acoustic output measurement standards to ensure substantial equivalence to its predicate device. The performance is documented through adherence to these standards rather than specific imaging metrics in this summary.
| Standard No. | Standard Title | Version | Device Performance |
|---|---|---|---|
| IEC 60601-1 | Medical Electrical Equipment - Part 1. General Requirements for Safety | 1988+A1:1991+A2:1995 | Conforms to applicable medical device safety standards in regards to thermal, mechanical, and electrical safety. |
| IEC 60601-1-2 | Medical Electrical Equipment, Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests | 2007 | Conforms to applicable medical device safety standards in regards to electromagnetic compatibility. |
| IEC 60601-2-37 | Medical Electrical Equipment, Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment | 2007 | Conforms to applicable medical device safety standards for ultrasonic medical diagnostic equipment. |
| NEMA UD 2 | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3 | 2004 (R 2009) | Acoustic output is measured and calculated per NEMA UID 2: 2004. |
| NEMA UD 3 | Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment | 2004 (R 2009) | Acoustic output is measured and calculated per NEMA UD3: 2004. |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity | 1999 | Conforms to applicable biocompatibility standards (in vitro cytotoxicity). |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity | 2002 | Conforms to applicable biocompatibility standards (irritation and delayed-type hypersensitivity). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical laboratory testing to verify the device's conformance to safety and performance standards. It does not mention a clinical test set involving human patient data the way AI/CAD devices typically do. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable or provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As there is no mention of a human-read clinical test set being used to assess the device's diagnostic performance (as it is a imaging system and not an AI/CAD system evaluated on diagnostic accuracy against human experts), this information is not applicable and not provided in the document.
4. Adjudication Method for the Test Set
Given that performance was assessed against engineering and safety standards rather than humanexpert interpretations of clinical images, an adjudication method for a test set is not applicable and not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This device is an ultrasound imaging system, not an AI or CAD (Computer-Aided Detection/Diagnosis) system. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with or without AI assistance is not applicable to this submission and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Again, this is an ultrasound imaging system, not an AI algorithm. A standalone performance evaluation in the context of an algorithm's diagnostic accuracy is not applicable here. The "standalone" performance for this device would be its ability to produce images and measurements according to its technical specifications, which was confirmed through laboratory testing against established standards.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this device's acceptance criteria is defined by recognized international and national standards for medical electrical equipment safety, electromagnetic compatibility, ultrasonic medical diagnostic equipment, acoustic output measurement, and biocompatibility. The device's conformance to these engineering and safety standards serves as its "ground truth."
8. The Sample Size for the Training Set
Since this is not an AI/Machine Learning device, the concept of a "training set" is not applicable. The device's functionality is based on established physics principles and engineering design, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of medical device, this information is not applicable.
{0}------------------------------------------------
APR 1 2 2013
510(k) Submission
510(k) Summary of Safety and Effectiveness
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
December 30, 2012
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | SonoScape Company Limited |
|---|---|
| Address: | Yizhe Building, Yuquan Road, Nanshan, Shenzhen518051, P.R.China |
| Contact Name: | Zhou Wenping |
| Telephone No.: | +86 755 26722890 |
| Fax No. : | +86 755 26722850 |
| Email Address: | Zhou@sonoscape.net / Faith@sonoscape.net |
3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]
| Trade Name: | S2 Portable Digital Color Doppler Ultrasound System | ||
|---|---|---|---|
| Common Name: | Diagnostic Ultrasound System and Transducers | ||
| Classification: | |||
| 21 CFR892.1550 Ultrasonic Pulsed Doppler Imaging System | Product code: IYN | ||
| 21 CFR892.1560 Ultrasonic Pulsed Echo Imaging System | Product code: IYO | ||
| 21 CFR892.1570 Diagnostic Ultrasonic Transducer | Product code: ITX | ||
| Classification Panel: | Radiology | ||
| Device Class: | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicates within this submission are as follows:
510(k) Summary of Safety and Effectiveness
{1}------------------------------------------------
K130119 Page 2 of 5
510(k) Submission
SonoScape Company Limited, Diagnostic Ultrasound System, Model S6 has been cleared by FDA through 510(k) No.K112602 (Decision Date – November 07, 2011).
5. Description of the Device [21 CFR 807.92(a)(4)]
The SonoScapeS2 Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D.
6. Intended Use [21 CFR 807.92(a)(5)]
The SonoScape S2 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| No. | Probe | Type | FrequencyRange | Intended Use |
|---|---|---|---|---|
| 1 | 2P1 | Phased Array | 2.0-4.0 MHz | Abdominal |
| Neonatal Cephalic | ||||
| No. | Probe | Type | FrequencyRange | Intended Use |
| Adult CephalicCardiac AdultCardiac Pediatric | ||||
| 2 | 5P1 | Phased Array | 4.0-7.0 MHz | PediatricNeonatal CephalicCardiac Pediatric |
| 3 | 6V1 | Micro-curvedArray | 4.0-8.0 MHz | Trans-rectalTrans-vaginal |
| 4 | 6V3 | Micro-curvedArray | 5.0-9.0 MHz | Trans-rectalTrans-vaginal |
| 5 | EC9-5 | Micro-curvedArray | 5.0-9.0 MHz | Trans-rectalTrans-vaginal |
| 6 | C611 | Micro-curvedArray | 4.0-8.0 MHz | AbdominalPediatricNeonatal CephalicCardiac Pediatric |
| 7 | C344 | curved Array | 2.0-5.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 8 | C362 | curved Array | 2.0-6.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 9 | VC6-2 | curved Array | 2.0-6.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 10 | L741 | Linear Array | 5.0-10.0 MHz | Small Organ (reast, thyroid,testes)Musculo-skeletal (Conventional)Peripheral vessel |
| 11 | L742 | Linear Array | 5.0-12.0 MHz | Small Organ (reast, thyroid,testes)Musculo-skeletal (Conventional)Musculo-skeletal (Superficial)Peripheral vessel |
| 12 | L743 | Linear Array | 5.0-10.0 MHz | Small Organ (reast, thyroid,testes)Musculo-skeletal (Conventional)Musculo-skeletal (Superficial)Peripheral vessel |
| 13 | C354 | curved Array | 2.0-5.0 MHz | Fetal / Abdominal/ Ob/GYN |
Table 1 Transducer Information
510(k) Summary of Safety and Effectiveness
{2}------------------------------------------------
K130119 Page 3 of 5
Portable Digital Color Doppler Ultrasound System
510(k) Submission
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KB0119 Page 4 of 5
510(k) Submission
510(k) Submission
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
Safety Considerations:
The S2 Portable Digital Color Doppler Ultrasound System with added transducer incorporates the same fundamental technology as the predicate device. The device has been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers "issued September 9, 2008. The acoustic output is measured and calculated per NEMA UID 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO10993-5and ISO 10993-10. Testing:
Laboratory testing was conducted to verify that the S2 Portable Digital Color Doppler Ultrasound System with added transducer met all design specification and was substantially equivalent to the currently marketed Predicate Device as above. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment".
| StandardsNo. | Standards Title | Version | Date |
|---|---|---|---|
| IEC 60601-1 | Medical Electrical Equipment - Part1.General Requirements for Safety | 1988+A1:1991+A2:1995 | 10/31/2005 |
| IEC60601-1-2 | Medical Electrical Equipment, Part 1-2:General Requirements for Safety –Collateral Standard: ElectromagneticCompatibility – Requirements and Tests | 2007 | 03/01/2007 |
| IEC | Medical Electrical Equipment, Part 2-37: | 2007 | 08/01/2007 |
Tab 2 Applicable Safety Standards
510(k) Summary of Safety and Effectiveness
{4}------------------------------------------------
K130119 Page 5f5
510(k) Submission
Portable Digital Color Doppler Ultrasound System
| 60601-2-37 | Particular Requirements for the Safety ofUltrasonic Medical Diagnostic andMonitoring Equipment | ||
|---|---|---|---|
| NEMA UD 2 | Acoustic Output Measurement Standard forDiagnostic Ultrasound Equipment Version 3 | 2004 | 01/01/2004(R 2009) |
| NEMA UD3 | Standard for Real-Time Display of Thermaland Mechanical Acoustic Output Indices onDiagnostic Ultrasound Equipment | 2004 | 01/01/2004(R 2009) |
| ISO 10993-5 | Biological evaluation of medical devices -Part 5: Tests for In Vitro cytotoxicity | 1999 | 09/12/2007 |
| ISO10993-10 | Biological evaluation of medical devices -Part 10: Tests for irritation and delayed-typehypersensitivity | 2002 | 09/01/2002 |
Results of performance and compliance testing conducted on the S2 Portable Digital Color Doppler Ultrasound System, indicates conformance to all applicable standards recognized by FDA for this device.
Based on non-clinical test results, $2 Portable Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices in safety and effectiveness.
9. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, SonoScape Company Limited concludes that S2 Portable Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices with regard to safety and effectiveness.
{5}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 12, 2013
SonoScape Company Limited % Miss Toki Wu Official Correspondent Yizhe Building, Yuquan Road Nanshan, Shenzhen 518051 P.R. CHINA
Re: K130119
Trade/Device Name: S2 Portable Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: December 28, 2012 Received: February 20, 2013
Dear Miss Wu:
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.
This determination of substantial equivalence applies to the following transducers intended for use with the S2 Portable Digital Color Doppler Ultrasound System, as described in your premarket notification:
Transducer Model Number
2P1 Phase Array 5P1 Phase Array 6V1 Micro-curved Array 6V3 Micro-curved Array EC9-5 Micro-curved Array C611 Micro-curved Array C362 Curved Array
C344 Curved Array C354 Curved Array VC6-2 Curved Array L743 Linear Array L741 Linear Array L742 Linear Array
{6}------------------------------------------------
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of 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/dcfault.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
Indications for Use
510(k) Number: K130119
Device Name: S2 Portable Digital Color Doppler Ultrasound System
Indications for Use:
The SonoScape S2 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
Prescription Use × (Part 21 CFR 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 (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) _______________________________________________________________________________________________________________________________________________________________________ K130119
{8}------------------------------------------------
System: SonoScape S2
Diagnostic Ultrasound Pulsed Echo System
Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intra-operative Specify. | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2 | ||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,5 | ||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3 | |
| FetalImaging&Other | Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3 |
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2 | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Cardiac Adult | P | P | P | P | P | P | Note 1 | Notes 2,3 | |
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3 | |
| Cardiac | Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2 | |
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color
Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: TDI Note 4: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) _______________________________________________________________________________________________________________________________________________________________________ K130119
Indications for Use
Page 2 of 15
{9}------------------------------------------------
Transducer: 2P1 Phase Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Power | Other* | Other* | |||||
| (TRACK 1 | (TRACKS 1 & 3) | B | M | PWD | CWD | Doppler | (Amplitude)Doppler | Combined | Specify | |
| ONLY) | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | Fetal | |||||||||
| Imaging&Other | Abdominal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3 | ||
| Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3 | ||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | Note 1 | Notes 2,3 | |
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3 | ||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color
Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) _______________________________________________________________________________________________________________________________________________________________________ K130119
{10}------------------------------------------------
Transducer: 5P1 Phase Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other* | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Combined | Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| FetalImaging&Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2 | |||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3 | ||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3 | ||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 4D
- Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k)
{11}------------------------------------------------
Transducer: 6V1 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Power | Other* | Other* | |||||
| (TRACK 1 | (TRACKS 1 & 3) | B | M | PWD | CWD | Doppler | (Amplitude) | Combined | Specify | |
| ONLY) | Doppler | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | Fetal | |||||||||
| Imaging& | Abdominal | |||||||||
| Other | Intra-operative Specify | |||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | P | P | p | P | P | Note 1 | Notes 2 | |||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2 | |||
| Trans-urethral | t | |||||||||
| Trans-esoph (non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Other (specify) |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) ======================================================================================================================================================================= K130119
Indications for Use
Page 5 of 15
{12}------------------------------------------------
Transducer: 6V3 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| FetalImaging&Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2 | |||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2 | |||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) · Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) _________K130119
{13}------------------------------------------------
Transducer: EC9-5 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other* | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Combined | Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| FetalImaging&Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2 | |||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2 | |||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph.(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K130119
Indications for Use
Page 7 of 15
{14}------------------------------------------------
Transducer: C611 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| FetalImaging&Other | Fetal | |||||||||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2 | |||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2 | |||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3 | ||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3 | ||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
i 510(k)
{15}------------------------------------------------
Transducer: C362 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | Fetal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Imaging &Other | Abdominal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2 | |||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color
Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 4D
- Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) == K130119
Indications for Use
Page 9 of 15
{16}------------------------------------------------
Transducer: C344 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other* | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Combined | Specify | ||
| Ophthalmic | Ophthalmic | ||||||||||
| FetalImaging&Other | Fetal | P | P | P | P | P | Note 1 | Notes 2 | |||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2 | ||||
| Intra-operative Specify | |||||||||||
| Intra-operative Neuro | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card) | |||||||||||
| Musculo-skeletal(Conventional) | |||||||||||
| Musculo-skeletal(Superficial) | |||||||||||
| Intravascular | |||||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2 | ||||
| Cardiac | Cardiac Adult | ||||||||||
| Cardiac Pediatric | |||||||||||
| Intravascular(Cardiac) | |||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Other (specify) | |||||||||||
| PeripheralVessel | Peripheral vessel | ||||||||||
| Other (specify) |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K130119
Indications for Use
Page 10 of 15
{17}------------------------------------------------
Transducer: C354 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |||
| Ophthalmic | Ophthalmic | |||||||||||
| Fetal | Fetal | N | N | N | N | N | Note 1 | Notes 2 | ||||
| Imaging& | Abdominal | N | N | N | N | N | Note 1 | Notes 2 | ||||
| Other | Intra-operative Specify | |||||||||||
| Intra-operative Neuro | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card) | ||||||||||||
| Musculo-skeletal | ||||||||||||
| (Conventional) | ||||||||||||
| Musculo-skeletal | ||||||||||||
| (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Ob/GYN) | N | N | N | Z | N | Note 1 | Notes 2 | |||||
| Cardiac | Cardiac Adult | |||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular(Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (specify) | ||||||||||||
| Peripheral | Peripheral vessel | |||||||||||
| Vessel | Other (specify) |
P = previously cleared by FDA; N = new indication; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) _______________________________________________________________________________________________________________________________________________________________________ K130119
Indications for Use
Page 11 of 15
{18}------------------------------------------------
Transducer: VC6-2 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic utrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Imaging &Other | Fetal | P | P | P | P | P | Note 1 | Notes 2,4 | |
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (specify) |
P = previously cieared by FDA; E = added under this appendix N = new indication; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 4: 4D Note 3: TDI
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130119 K130119 510(k) =======================================================================================================================================================================
Indications for Use
Page 12 of 15
{19}------------------------------------------------
Transducer: L743 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging&Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2 | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2 | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2 | |
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) _______________________________________________________________________________________________________________________________________________________________________ K130119
{20}------------------------------------------------
Transducer: L741 Linear Array
Diagnostic Ultrasound Transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | Fetal | |||||||||
| Imaging&Other | Abdominal | |||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,5 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph (non-Card) | ||||||||||
| Musculo-skeletal | P | P | P | P | P | Note 1 | Notes 2 | |||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2 | ||
| Vessel | Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K130119
Indications for Use
Page 14 of 15
{21}------------------------------------------------
Transducer: L742 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | Fetal | ||||||||
| Imaging&Other | Abdominal | ||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,5 | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal | P | P | P | P | P | Note 1 | Notes 2 | ||
| (Conventional) | |||||||||
| Musculo-skeletal | P | P | P | P | P | Note 1 | Notes 2 | ||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2 | |
| Vessel | Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130119 510(k)
§ 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.