PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
Device Facts
| Record ID | K123616 |
|---|---|
| Device Name | PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM |
| Applicant | Sonoscape Company Limited |
| Product Code | IYO · Radiology |
| Decision Date | Dec 21, 2012 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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, portable ultrasound device. It projects ultrasound waves into body tissue via linear or convex array probes (2.0–12 MHz) and processes returned echoes. The system displays images in B-Mode, M-Mode, and Tissue Harmonic Imaging (THI) mode, or combined B/M-Mode. Used in clinical settings by qualified physicians for diagnostic imaging and fluid flow analysis. The device provides real-time visual output on a monitor to assist in clinical evaluation of various anatomical structures and physiological states. It aids in diagnostic decision-making by providing anatomical visualization and flow information, potentially benefiting patients through non-invasive diagnostic assessment.
Clinical Evidence
No clinical testing was required. Substantial equivalence is supported by bench testing, including electrical safety, electromagnetic compatibility, and acoustic output measurements.
Technological Characteristics
Portable ultrasound system; B-Mode, M-Mode, and THI imaging. Transducers: linear and convex arrays (2.0–12 MHz). Biocompatible patient-contact materials. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasonic performance), NEMA UD 2-2004 (acoustic output). Software-controlled.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in adults, pregnant women, pediatric, and neonate populations. Applications include abdomen, cardiac, small organs (thyroid, parathyroid, parotid, submaxillary gland, testes, breast), peripheral vascular, transvaginal, transrectal, musculoskeletal (conventional/superficial), fetal, OB/GYN, and urology.
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
- SonoScape A6 Portable Ultrasonic Diagnostic System (K101337)
Related Devices
- K101337 — A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM · Sonoscape Company Limited · Sep 30, 2010
- K053346 — MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 9, 2005
- 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
- K043563 — DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 11, 2005
Submission Summary (Full Text)
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K123616
SonoScape Company LTD
# A6 Portable Ultrasonic Diagnostic System
# Tab 4 510(k) Summary
# DEC 2 1 2012
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:
Date of submission: November 15, 2012
Submitter:
SonoScape Company Limited
Address: 4F, Yizhe Building, Yuquan Road, Nanshan, Shenzhen 518051, P.R.China
Tel: (86) 755-26722890
Fax: (86) 755-26722850
Contact Person: Zhou Wenping
# Submission Correspondent:
Ms. Diana Hong & Mr. Lee Fu
Mid-Link Consulting Co., Ltd
P.O. Box 237-023, Shanghai, 200237, China
Tel: +86-21-22815850
Fax: 240-238-7587
Email: info@mid-link.net
# Proposed Device Identification:
* 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)
.
510(k) Summary
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# 21 CFR 892.1570 Diagnostic Ultrasound Transducer(90-ITX)
## Legally Marketed Predicate Device:
SonoScape A6 Portable Ultrasonic Diagnostic System 510(k) Number: K101337
## Description:
The A6 Portable Ultrasonic Diagnostic System with added transducer is a general purpose, portable, software controlled and 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 and 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.
## Intended Use Statement:
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 t 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 Secking 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
: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
510(k) Summary
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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:
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 Predicate Device. 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". .....
IEC 60601-1; 2005 Medical Electrical Equipment - Part 1: General Requirements for Safety IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests. IEC 60601-2-37: 2008 Medical electrical equipment -- Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring i ..:.... ::::: . . . . . . . ... : .. .. equipment.
NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3.
### Clinical Test:
No clinical testing was required.
### Substantially Equivalent Conclusion
The proposed device, A6 Portable Ultrasonic Diagnostic System, is determined to be Substantially Equivalent (SE) to the predicate device in respect of safety and effectiveness.
### 510(k) Summary
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with stylized wings.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
SonoScape Company Limited % Ms. Diana Hong & Mr. Lee Fu General Manager Mid-Link Consulting Co., Ltd. P.O. Box 237-023, Shanghai, 200237 CHINA
DEC 2 1 2012
Re: K123616.
Trade/Device Name: 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: November 23, 2012 Received: November 23, 2012
Dear Ms. Hong:
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 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 Micro-curved Array
C351 Curved Array C352 Curved Array C543 Curved Array L745 Linear Array L746 Linear Array
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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,
Janine M. Morris
Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure(s)
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# Tab 2 Indications for Use
510(k) Number: K123616
Device Name: Portable Ultrasonic Diagnostic System ·
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, submaxillar, gland, testes Vascular, Trans-vaginal, Trans-rectal, Musculo-skeletal and breast.), Peripheral (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology. This device is intended to adult, pregnant woman, pediatric, and neonate.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LANE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of *In Vitro* Diagnostics and Radiological Health (OIR)
(Division Sign Off)
Division of Radiological Health
Office of *In Vitro* Diagnostic and Radiological Health
510(k) K123616
### Tab 2 Indications for use
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### System: SonoScape A6 Diagnostic Ultrasound Pulsed Echo System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | Mode of Operation | | | | | | Other* | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|----------|----------|
| | | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Combined | Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal<br>Abdominal | P | P | | | | | Note 1 | Note 2 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | | | | | Note 1 | Note 2 |
| | Small Organ (specify) | P | P | | | | | Note 1 | Note 2,3 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | | | | | Note 1 | Note 2 |
| | Trans-vaginal | P | P | | | | | Note 1 | Note 2 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | | | | | Note 1 | Note 2 |
| | Musculo-skeletal<br>(Superficial) | P | P | | | | | Note 1 | Note 2 |
| | Intravascular | | | | | | | | |
| | Other (Urology) | P | P | | | | | Note 1 | Note 2 |
| | Other (Ob/GYN) | P | P | | | | | Note 1 | Note 2 |
| Cardiac | Cardiac Adult | P | P | | | | | Note 1 | Note 2 |
| | Cardiac Pediatric | P | P | | | | | Note 1 | Note 2 |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | | | | | Note 1 | Note 2 |
N = new indication;
Note 1: B/M
Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.
Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)
(Division Sign Off)
Division of Radiological Health
Tab 2 Indications for use
Office of In Vitro Diagnostics and Radiological Health
510(K) K123616
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#### 6V4 Micro-curved Array Transducer: 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 | P | P | | | | | Note 1 | Note 2 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| | Other (Ob/GYN) | P | P | | | | | 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. Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)
Sammy Thomas
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
510(k) K123616
{8}------------------------------------------------
#### 6V5 Micro-curved Array Transducer: 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 | P | P | | | | | Note 1 | Note 2 |
| | Trans-vaginal | P | P | | | | | Note 1 | Note 2 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Urology) | P | P | | | | | Note 1 | Note 2 |
| | Other (Ob/GYN) | P | P | | | | | 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.
Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics and R
2-4
510(k) K123616
{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 | | | | | | Other* | |
|------------------------------|------------------------------------|---|-------------------|-----|-----|------------------|---------------------------------|----------|---------|--|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Combined | 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 | P | P | | | | | Note 1 | Note 2 | |
| | Trans-vaginal | P | P | | | | | Note 1 | Note 2 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Urology) | P | P | | | | | Note 1 | Note 2 | |
| | Other (Ob/GYN) | P | P | | | | | 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.
Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)
(Division Sign Off)
Division of Radiological Health
Indications for use
Office of In Vitro Diagnostics and Radiological Health
510(k) K123616
{10}------------------------------------------------
#### BCC9-4 Micro-curved Array Transducer: 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 | | | | | | | | |
| | Trans-rectal | P | P | | | | | Note 1 | Note 2 |
| | Trans-vaginal | P | P | | | | | Note 1 | Note 2 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Urology) | P | P | | | | | Note 1 | Note 2 |
| | Other (Ob/GYN) | P | P | | | | | 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. Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)
(Division Sign Off)
Division of Radiological Health
Indications for use
Office of In Vitro Diagnostics and Radiological Health
510(k) K123616
{11}------------------------------------------------
#### C612 Micro-curved Array Transducer: 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 | P | P | | | | | Note 1 | Note 2 |
| | Intra-operative Specify<br>Intra-operative Neuro | | | | | | | | |
| | Laparoscopic<br>Pediatric<br>Small Organ (specify) | P | P | | | | | Note 1 | Note 2 |
| | Neonatal Cephalic<br>Adult Cephalic | | | | | | | | |
| | Trans-rectal<br>Trans-vaginal | | | | | | | | |
| | Trans-urethral<br>Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular<br>Other (Urology)<br>Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult<br>Cardiac Pediatric | P | P | | | | | Note 1 | Note 2 |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac)<br>Intra-cardiac<br>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. Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)
(Division Sign Off)
2.
# Indications for use
Division of Radiological Health ാനിറേ of In Vitro Diagnostics and Radiological Health
510(k) K123616
{12}------------------------------------------------
#### C312 Micro-curved Array Transducer: 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) | P | P | P | | | | Note 1 | Note 2 |
| 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. Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)
Sam Thain
(Division Sign Off)
Division of Radiological Health
Office of in Vitro Diagnostics and
510(k) K123616
{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 | P | P | | | | | Note 1 | Note 2 |
| | Abdominal | P | P | | | | | 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) | P | P | | | | | Note 1 | Note 2 |
| | Other (Ob/GYN) | P | P | | | | | 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. Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)
Danu Than
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiolo
510(k) K123616
2-9
{14}------------------------------------------------
#### C352 Curved Array Transducer: 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 | P<br>P | P<br>P | | | | | Note 1<br>Note 1 | Note 2<br>Note 2 |
| | 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 | | | | | | | | |
| | Other (Urology)<br>Other (Ob/GYN) | P<br>P | P<br>P | | | | | Note 1<br>Note 1 | Note 2<br>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. Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radio
510(k) K123616
2-10
{15}------------------------------------------------
#### C543 Curved Array Transducer: 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 | P | P | | | | | Note 1 | Note 2 |
| | | Intra-operative Specify | | | | | | | | |
| | | Intra-operative Neuro | | | | | | | | |
| | | Laparoscopic | | | | | | | | |
| | | Pediatric | P | P | | | | | 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) | | | | | | | | |
| Cardiac | | Intravascular | | | | | | | | |
| | | Other (Urology) | | | | | | | | |
| | | Other (Ob/GYN) | | | | | | | | |
| | | Cardiac Adult | | | | | | | | |
| | | Cardiac Pediatric | | | | | | | | |
| | | Intravascular(Cardiac) | | | | | | | | |
| | | Trans-esoph. (Cardiac) | | | | | | | | |
| | | Intra-cardiac | | | | | | | | |
| Peripheral<br>Vessel | | Other (specify) | | | | | | | | |
| | | 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. Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)
Dan Thom
(Division Sign Off)
División of Radiological Health
Office of In Vitro Diagnostics and Radiological
510(k) K123616
Indications for use
{16}------------------------------------------------
#### L745 Linear Array Transducer: 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) | P | P | P | | | | Note 1 | Note 2,3 |
| | | Neonatal Cephalic | | | | | | | | |
| | | Adult Cephalic | | | | | | | | |
| | | Trans-rectal | | | | | | | | |
| | | Trans-vaginal | | | | | | | | |
| | | Trans-urethral | | | | | | | | |
| | | Trans-esoph.(non-Card) | | | | | | | | |
| | | Musculo-skeletal<br>(Conventional) | P | P | P | | | | Note 1 | Note 2 |
| | | Musculo-skeletal<br>(Superficial) | P | P | P | | | | Note 1 | Note 2 |
| | | 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 | P | P | P | | | | Note 1 |
| | | | 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. Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)
(Division Sign Off)
Division of Radiological Hea
Office of In Vitro Diagnostics and Radio
510(k) K123616
2-12
{17}------------------------------------------------
#### L746 Linear Array Transducer: 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 | | | | | | | | | |
|…
