A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
Device Facts
| Record ID | K101337 |
|---|---|
| Device Name | A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM |
| Applicant | Sonoscape Company Limited |
| Product Code | IYO · Radiology |
| Decision Date | Sep 30, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The A6 Portable Ultrasonic Diagnostic System with added transducer is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.), Peripheral Vascular, Transvaginal, Transrectal, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology. This device is intended to adult, pregnant woman, pediatric, and neonate.
Device Story
A6 Portable Ultrasonic Diagnostic System is a software-controlled, general-purpose ultrasound imaging device. It projects ultrasound waves into body tissue and processes returned echoes to generate images in B-Mode, M-Mode, and Tissue Harmonic Imaging (THI). The system utilizes various linear and micro-curved array probes (2.0 MHz to 12 MHz). It is intended for use by qualified physicians in clinical settings for diagnostic evaluation of multiple anatomical regions. The device displays real-time echo information on a monitor, assisting clinicians in visualizing internal structures and fluid flow. This diagnostic information supports clinical decision-making across various specialties, including OB/Gyn, cardiology, and urology, providing non-invasive imaging benefits to patients.
Clinical Evidence
No clinical testing was required. Substantial equivalence was demonstrated through bench testing, including thermal, mechanical, and electrical safety verification, and acoustic output measurements per NEMA UD 2-2004.
Technological Characteristics
Portable ultrasound system; B-Mode, M-Mode, and THI imaging; 2.0-12 MHz frequency range; linear and micro-curved array transducers. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and NEMA UD 2. Patient-contact materials are biocompatible per ISO 10993-5 and ISO 10993-10.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in adults, pregnant women, pediatric, and neonate populations for abdomen, cardiac, small organs, peripheral vascular, transvaginal, transrectal, musculoskeletal, fetal, OB/Gyn, and urology applications.
Regulatory Classification
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- DP-9900 Digital Ultrasonic Diagnostic Imaging System (K070526)
- SSI-600 Portable Diagnostic Ultrasound System (K041455)
- SSI-1000 Portable Color Doppler Ultrasound System (K052042)
Related Devices
- K123616 — PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM · Sonoscape Company Limited · Dec 21, 2012
- K061189 — DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 1, 2006
- K063500 — DC-6 DIAGNOSTIC ULTRASOUND SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 6, 2006
- K053346 — MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 9, 2005
- K122010 — Z6 DIAGNOSTIC ULTRASOUND SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 20, 2012
Submission Summary (Full Text)
{0}------------------------------------------------
# Tab 20 PREMARKET NOTIFICATION 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
Date of submission: 03 SEPT 2010
Submitter:
SonoScape Company Limited
Address: 4/F., Yizhe Building, Yuquan Road,Nanshan, Shenzhen 518051, P.R.China
Tel: (86) 755-26722890
Fax: (86) 755-26722850
Contact Person: Zhiqiang Chen
Name of the device:
.
* Trade/Proprietary Name: A6 Portable Ultrasonic Diagnostic System
* Common Name: Diagnostic Ultrasound System and Transducers * Classification:
Regulatory Class: II
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-1TX)
### Legally Marketed Predicate Device:
K070526, DP-9900 Digital Ultrasonic Diagnostic Imaging System K041455, SSI-600 Portable Diagnostic Ultrasound System K052042, SSI-1000 Portable Color Doppler Ultrasound System
{1}------------------------------------------------
### Description:
The A6 Portable Ultrasonic Diagnostic System with added transducer is a general purpose, portable, software controlled, ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode, THI- Mode or in the combined mode (i.e. B/M-Mode). This system is a Track I device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.0 MHz to 12 MHz.
### Statement of intended Use:
The A6 Portable Ultrasonic Diagnostic System with added transducer is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.), Peripheral Vascular, Transvaginal, Transrectal, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology. This device is intended to adult, pregnant woman, pediatric, and neonate.
### Technological Characteristics:
The A6 Portable Ultrasonic Diagnostic System with added transducer incorporates the same fundamental technology as the predicate device. The device has been tested as Track 1 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 UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004. All transducers used with the A6 Portable Ultrasonic Diagnostic System are track 1. All patient contact materials are biocompatible. The technology characteristics of the A6 Portable Ultrasonic Diagnostic System with these modifications do not affect the safety or efficacy of the device.
#### Testing:
Premarket Notification 510(k) Summary
20-2
{2}------------------------------------------------
SonoScape Company LTD
Laboratory testing was conducted to verify that the A6 Portable Ultrasonic Diagnostic 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".
| Standards No. | Standards Title | Version | Date |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------|
| IEC 60601-1 | IEC 60601-1, Medical Electrical Equipment - Part 1:<br>General Requirements for Safety, 1988; Amendment 1,<br>1991-11, Amendment 2, 1995. | 1988 | 10/31/2005 |
| IEC 60601-1-2 | IEC 60601-1-2, (Second Edition, 2001), Medical<br>Electrical Equipment - Part 1-2: General Requirements<br>for Safety - Collateral Standard: Electromagnetic<br>Compatibility -- Requirements and Tests. | 2001 | 07/31/2008 |
| IEC<br>60601-2-37 | IEC 60601-2-37 (2004) (2005) Amendment 2, Medical<br>electrical equipment - Part 2-37: Particular requirements<br>for the basic safety and essential performance of<br>ultrasonic medical diagnostic and monitoring equipment. | 2004 | 09/08/2009 |
| NEMA UD 2 | NEMA UD 2-2004, Acoustic Output Measurement<br>Standard for Diagnostic Ultrasound Equipment Version 3. | 2004 | 09/08/2009 |
| ISO 10993-5 | ISO 10993-5:1999, Biological evaluation of medical<br>devices - Part 5: Tests for In Vitro cytotoxicity. | 1999 | 09/12/2007 |
| 10993-10 | ISO 10993-10:2002, Biological evaluation of medical<br>devices - Part 10: Tests for irritation and delayed-type<br>hypersensitivity. | 2002 | 09/12/2007 |
## Tab 20.1 Applicable Safety Standards
### Clinical Test:
No clinical testing was required
#### Conclusion:
The conclusions drawn from testing of the A6 Portable Ultrasonic Diagnostic System with
added transducer demonstrates that the devices as safe, as effective as well as the
legally marketed predicate devices.
{3}------------------------------------------------
Image /page/3/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 lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SonoScape Company Limited % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062
Re: K101337
SEP 3 0 2010
Trade/Device Name: A6 Portable Ultrasonic Diagnostic System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: September 16, 2010 Received: September 21, 2010
Dear Mr. Devine:
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 A6 Portable Ultrasonic Diagnostic System, as described in your premarket notification:
### Transducer Model Number
6V4 Micro-curved Array 6V5 Micro-curved Array EC2 Micro-curved Array BCC9-4 Micro-curved Array C612 Micro-curved Array C312 Mirco-curved Array
C351 Curved Array C352 Curved Array C543 Curved Array L745 Linear Array L746 Linear Array
{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 895. 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 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 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely yours,
Sincerely yours,
David C. Rowe, Ph.D.
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{5}------------------------------------------------
A6 Portable Ultrasonic Diagnostic System
# Tab 3 Indications For Use
· 510(k) Number: K101337
Device Name: A6 Portable Ultrasonic Diagnostic System
SEP 3 0 2010
Indications for Use:
The A6 Portable Ultrasonic Diagnostic System with added transducer is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast), Peripheral Vascular, Transvaginal, Transrectal, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology. This device is intended to adult, pregnant woman, pediatric, and neonate.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K101337
{6}------------------------------------------------
### System: Sonoscape A6 Diagnostic Ultrasound Pulsed Echo System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|---|-------------------|-----|-----|------------------|---------------------------------|--------------------|-------------------|--|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | N | N | | | | | Note 1 | Note 2 | |
| | Abdominal | N | N | | | | | Note 1 | Note 2 | |
| | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | | | | | Note 1 | Note 2 | |
| | Small Organ (specify) | N | N | | | | | Note 1 | Note 2,3 | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | N | N | | | | | Note 1 | Note 2 | |
| | Trans-vaginal | N | N | | | | | Note 1 | Note 2 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | | | | | Note 1 | Note 2, 3 | |
| | Musculo-skeletal<br>(Superficial) | N | N | | | | | Note 1 | Note 2, 3 | |
| | Intravascular | | | | | | | | | |
| | Other (Urology) | N | N | | | | | Note 1 | Note 2 | |
| | Other (Ob/GYN) | N | N | | | | | Note 1 | Note 2 | |
| Cardiac | Cardiac Adult | N | N | | | | | Note 1 | Note 2 | |
| | Cardiac Pediatric | N | N | | | | | Note 1 | Note 2 | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | | | | | Note 1 | Note 2 | |
| | Other (specify) | | | | | | | | | |
N = new indication; Note 1: B/M
Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.
P = previously cleared by FDA;
Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)
(Division Sign-Off)
E = added under this appendix
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K101337
{7}------------------------------------------------
### Transducer: 6V4 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | N | N | | | | | Note 1 | Note 2 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| Cardiac | Other (Ob/GYN) | N | N | | | | | Note 1 | Note 2 |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |
N = new indication;
P = previously cleared by FDA;
E = added under this appendix
Note 1: B/M
Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.
.
(Division Sign-Off)
(Division of Radiological Devices Division of Radiological Devices Evaluation and Safety
510K K106337
{8}------------------------------------------------
## Transducer: 6V5 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (specify) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | N | N | | | | | Note 1 | Note 2 | |
| | Trans-vaginal | N | N | | | | | Note 1 | Note 2 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Urology) | N | N | | | | | Note 1 | Note 2 | |
| | Other (Ob/GYN) | N | N | | | | | Note 1 | Note 2 | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
N = new indication;
P = previously cleared by FDA;
E = added under this appendix
Note 1: B/M
Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
K101332
510K
{9}------------------------------------------------
### Transducer: EC2 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (specify) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | N | N | | | | | Note 1 | Note 2 | |
| | Trans-vaginal | N | N | | | | | Note 1 | Note 2 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Urology) | N | N | | | | | Note 1 | Note 2 | |
| | Other (Ob/GYN) | N | N | | | | | Note 1 | Note 2 | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| N = new indication; P = previously cleared by FDA; E = added under this appendix | | | | | | | | | | |
N = new indication;
- new indication,
Note 1: B/M Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K101337
{10}------------------------------------------------
### Transducer: BCC9-4 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal<br>Abdominal<br>Intra-operative Specify<br>Intra-operative Neuro<br>Laparoscopic<br>Pediatric<br>Small Organ (specify)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-rectal | N | N | | | | | Note 1 | Note 2 | |
| | Trans-vaginal | N | N | | | | | Note 1 | Note 2 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Urology) | N | N | | | | | Note 1 | Note 2 | |
| | Other (Ob/GYN) | N | N | | | | | Note 1 | Note 2 | |
| Cardiac | Cardiac Adult<br>Cardiac Pediatric<br>Intravascular(Cardiac)<br>Trans-esoph.(Cardiac)<br>Intra-cardiac<br>Other (specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel<br>Other (specify) | | | | | | | | | |
N = new indication;
P = previously cleared by FDA;
E = added under this appendix
Note 1: B/M
Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.
***_*****_**, the one that is.
Division of Radiological Devices Office of in Vitro Diagnostic Device Evaluation and Safety
K10133-7
510K
{11}------------------------------------------------
## Transducer: C612 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal<br>Abdominal | N | N | | | | | Note 1 | Note 2 | |
| | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | | | | | Note 1 | Note 2 | |
| | Small Organ (specify) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Urology) | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | N | N | | | | | Note 1 | Note 2 | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
N = new indication;
P = previously cleared by FDA;
E = added under this appendix
Note 1: B/M
Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.
કાબ્દ
(Division Sign-Off)
Division of Radiological Devices
untic Device Evaluation and Safety
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Office of In Vitro Diagnostic Device Evaluation and Safety
.
{12}------------------------------------------------
### Transducer: C312 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal<br>Abdominal<br>Intra-operative Specify<br>Intra-operative Neuro<br>Laparoscopic<br>Pediatric<br>Small Organ (specify)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Trans-urethral<br>Trans-esoph.(non-Card)<br>Musculo-skeletal<br>(Conventional)<br>Musculo-skeletal<br>(Superficial)<br>Intravascular<br>Other (Urology)<br>Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult<br>Cardiac Pediatric<br>Intravascular(Cardiac)<br>Trans-esoph.(Cardiac)<br>Intra-cardiac<br>Other (specify) | N | N | | | | | Note 1 | Note 2 |
| Peripheral<br>Vessel | Peripheral vessel<br>Other (specify) | | | | | | | | |
N = new indication;
indication;
P = previously cleared by FDA;
E = added under this appendix
Note 1: B/M
Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.
signature
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K101337
{13}------------------------------------------------
### Transducer: C351 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | N | N | | | | | Note 1 | Note 2 | |
| | Abdominal | N | N | | | | | Note 1 | Note 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<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Urology) | N | N | | | | | Note 1 | Note 2 | |
| | Other (Ob/GYN) | N | N | | | | | Note 1 | Note 2 | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
N = new indication;
P = previously cleared by FDA;
E = added under this appendix
Note 1: B/M
Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.
(Division Sign-Off)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
K101337
510K
:
{14}------------------------------------------------
## Transducer: C352 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | N | N | | | | | Note 1 | Note 2 | |
| | Abdominal | N | N | | | | | Note 1 | Note 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<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Urology) | N | N | | | | | Note 1 | Note 2 | |
| | Other (Ob/GYN) | N | N | | | | | Note 1 | Note 2 | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
N = new indication;
P = previously cleared by FDA;
E = added under this appendix
Note 1: B/M
Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.
(Division Sign-Off)
(Division Sign-Off)
Division of Rediological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K101337
{15}------------------------------------------------
### Transducer: C543 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | |
| | Abdominal | N | N | N | | | | Note 1 | Note 2 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | | | Note 1 | Note 2 |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |
N = new indication;
Note 1: B/M
Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.
(Division Sign-Off) (Division of Radiological Devices Division of Radiological Devices
Office of In Vitro Diegnostic Device Evaluation and Safety
510K K101337
{16}------------------------------------------------
### Transducer: L745 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal<br>Abdominal<br>Intra-operative Specify<br>Intra-operative Neuro<br>Laparoscopic<br>Pediatric<br>Small Organ (specify)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Trans-urethral<br>Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | | | | | Note 1 | Note 2,3 |
| | Musculo-skeletal<br>(Superficial) | N | N | | | | | Note 1 | Note 2,3 |
| | Intravascular<br>Other (Urology)<br>Other (Ob/GYN) | | | | | |…
