(141 days)
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.
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.
The provided document describes the SonoScape A6 Portable Ultrasonic Diagnostic System and its associated transducers. The submission is a 510(k) Pre-Market Notification, indicating a device seeking clearance for being substantially equivalent to a legally marketed predicate device, rather than a novel device requiring extensive clinical trials for efficacy.
Here's a breakdown of the information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for its diagnostic performance, nor does it report specific performance metrics for the device in a clinical context. Instead, the acceptance criteria are based on adherence to recognized safety and performance standards for diagnostic ultrasound equipment. The "performance" in this context refers to meeting these established standards, which serve as a proxy for substantial equivalence and safety/effectiveness.
| Acceptance Criterion (Standard Met) | Reported Device Performance |
|---|---|
| Safety Standards | |
| IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Safety | Device found to conform to applicable medical device safety standards for thermal, mechanical, and electrical safety. |
| IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility | Device found to conform to applicable medical device safety standards for electromagnetic compatibility. |
| IEC 60601-2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | Device found to conform to applicable medical device safety standards for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. |
| Acoustic Output Standards | |
| NEMA UD 2-2004: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment | Acoustic output is measured and calculated according to this standard, ensuring levels are within safe limits. The device is classified as a Track 1 device, meaning its acoustic output is within "Track 1" limits as defined by FDA guidance, suggesting a presumption of safety given established usage. |
| Biocompatibility Standards | |
| ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity | All patient contact materials are biocompatible, and the device has been tested against this standard. |
| ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity | All patient contact materials are biocompatible, and the device has been tested against this standard, ensuring no irritation or hypersensitivity from patient-contact materials. |
| Substantial Equivalence | The device (A6 Portable Ultrasonic Diagnostic System with added transducer) demonstrates substantial equivalence to legally marketed predicate devices (K070526, K041455, K052042) in terms of intended use, technological characteristics, safety, and efficacy, based on laboratory testing and adherence to recognized standards. No clinical testing was required for this 510(k) clearance. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical testing was required." This means there was no specific "test set" of patient data or samples used in the way one would for a clinical efficacy study. The testing performed was primarily laboratory-based to meet engineering and safety standards. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical testing was required and therefore no clinical "test set" was used, there were no experts establishing ground truth for such a set. The "ground truth" for this device's clearance is its adherence to universally recognized safety and performance standards, verified through laboratory testing.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used for diagnostic performance evaluation or adjudication. The evaluation was primarily against engineering and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
No MRMC comparative effectiveness study was mentioned or required for this 510(k) clearance. The device is a general-purpose ultrasound system, and its clearance relies on proving substantial equivalence to existing predicate ultrasound devices, not on demonstrating improved diagnostic performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a diagnostic ultrasound system, which inherently involves human operation and interpretation. It is not an AI algorithm performing diagnostic tasks independently.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the adherence to established international and national standards for medical electrical equipment safety (IEC 60601 series), acoustic output (NEMA UD 2), and biocompatibility (ISO 10993 series). The performance of the device's components and overall system was verified against the requirements outlined in these standards, in comparison to existing legally marketed predicate ultrasound devices.
8. The Sample Size for the Training Set
Not applicable. As a general-purpose diagnostic ultrasound system, this device's functionality is based on established physics and engineering principles of ultrasound imaging, not on machine learning or AI algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device submission.
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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
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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:General Requirements for Safety, 1988; Amendment 1,1991-11, Amendment 2, 1995. | 1988 | 10/31/2005 |
| IEC 60601-1-2 | IEC 60601-1-2, (Second Edition, 2001), MedicalElectrical Equipment - Part 1-2: General Requirementsfor Safety - Collateral Standard: ElectromagneticCompatibility -- Requirements and Tests. | 2001 | 07/31/2008 |
| IEC60601-2-37 | IEC 60601-2-37 (2004) (2005) Amendment 2, Medicalelectrical equipment - Part 2-37: Particular requirementsfor the basic safety and essential performance ofultrasonic medical diagnostic and monitoring equipment. | 2004 | 09/08/2009 |
| NEMA UD 2 | NEMA UD 2-2004, Acoustic Output MeasurementStandard for Diagnostic Ultrasound Equipment Version 3. | 2004 | 09/08/2009 |
| ISO 10993-5 | ISO 10993-5:1999, Biological evaluation of medicaldevices - Part 5: Tests for In Vitro cytotoxicity. | 1999 | 09/12/2007 |
| 10993-10 | ISO 10993-10:2002, Biological evaluation of medicaldevices - Part 10: Tests for irritation and delayed-typehypersensitivity. | 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.
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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)
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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
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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:
| 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 | 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(Conventional) | N | N | Note 1 | Note 2, 3 | ||||||
| Musculo-skeletal(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) | ||||||||||
| PeripheralVessel | 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(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 | |||||||||
| Trans-vaginal | N | N | Note 1 | Note 2 | |||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(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) | |||||||||
| PeripheralVessel | 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(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 | N | N | Note 1 | Note 2 | ||||||
| Trans-vaginal | N | N | Note 1 | Note 2 | ||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(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) | ||||||||||
| PeripheralVessel | 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(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 | N | N | Note 1 | Note 2 | ||||||
| Trans-vaginal | N | N | Note 1 | Note 2 | ||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(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) | ||||||||||
| PeripheralVessel | 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(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| FetalImaging&Other | FetalAbdominalIntra-operative SpecifyIntra-operative NeuroLaparoscopicPediatricSmall Organ (specify)Neonatal CephalicAdult CephalicTrans-rectal | N | N | Note 1 | Note 2 | |||||
| Trans-vaginal | N | N | Note 1 | Note 2 | ||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Urology) | N | N | Note 1 | Note 2 | ||||||
| Other (Ob/GYN) | N | N | Note 1 | Note 2 | ||||||
| Cardiac | Cardiac AdultCardiac PediatricIntravascular(Cardiac)Trans-esoph.(Cardiac)Intra-cardiacOther (specify) | |||||||||
| PeripheralVessel | Peripheral vesselOther (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(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| FetalImaging&Other | FetalAbdominal | 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(Conventional) | ||||||||||
| Musculo-skeletal(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) | ||||||||||
| PeripheralVessel | 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(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging&Other | FetalAbdominalIntra-operative SpecifyIntra-operative NeuroLaparoscopicPediatricSmall Organ (specify)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalTrans-urethralTrans-esoph.(non-Card)Musculo-skeletal(Conventional)Musculo-skeletal(Superficial)IntravascularOther (Urology)Other (Ob/GYN) | ||||||||
| Cardiac | Cardiac AdultCardiac PediatricIntravascular(Cardiac)Trans-esoph.(Cardiac)Intra-cardiacOther (specify) | N | N | Note 1 | Note 2 | ||||
| PeripheralVessel | Peripheral vesselOther (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(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| FetalImaging&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(Conventional) | ||||||||||
| Musculo-skeletal(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) | ||||||||||
| PeripheralVessel | 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(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| FetalImaging&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(Conventional) | ||||||||||
| Musculo-skeletal(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) | ||||||||||
| PeripheralVessel | 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(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging&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(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Urology) | |||||||||
| 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;
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(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging&Other | FetalAbdominalIntra-operative SpecifyIntra-operative NeuroLaparoscopicPediatricSmall Organ (specify)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card) | ||||||||
| Musculo-skeletal(Conventional) | N | N | Note 1 | Note 2,3 | |||||
| Musculo-skeletal(Superficial) | N | N | Note 1 | Note 2,3 | |||||
| IntravascularOther (Urology)Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac AdultCardiac PediatricIntravascular(Cardiac)Trans-esoph. (Cardiac)Intra-cardiacOther (specify) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | Note 1 | Note 2 | ||||
| Other (specify) |
N = new indication;
P = previously cleared by FDA;
510K
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 Devices Office of in Vitro Diagnostic Device Evaluation and Safety
Indications for use
·
{17}------------------------------------------------
Transducer: L746 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 | FetalAbdominalIntra-operative SpecifyIntra-operative NeuroLaparoscopicPediatricSmall Organ (specify)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card)Musculo-skeletal(Conventional)Musculo-skeletal(Superficial)IntravascularOther (Urology)Other (Ob/GYN) | N | N | Note 1 | Note 2,3 | ||||
| Cardiac | Cardiac AdultCardiac PediatricIntravascular(Cardiac)Trans-esoph. (Cardiac)Intra-cardiacOther (specify) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | Note 1 | Note 2 | ||||
| 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.)
signature
(Division Sign-Gify Division of Radiological Devices - Emotor of Nationogical Devices
Vitro Diagnostic Device Evaluation and Safety
510K K10/32-
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.