(44 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound imaging modes and processing.
No.
The device is described as a "Diagnostic Ultrasound System" intended to "acquire and display ultrasound images" for various exams, which are diagnostic purposes, not therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section explicitly states "The DC-N3/DC-N3S Diagnostic Ultrasound System is applicable for adult, pregnant woman, pediatric and neonate." and the "Device Description" section states it is a "software controlled, ultrasound diagnostic system."
No
The device description explicitly states it is a "Diagnostic Ultrasound System" and employs "an array of probes," which are hardware components essential for acquiring ultrasound images. While it is software-controlled and performs image processing, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The DC-N3/DC-N3S Diagnostic Ultrasound System uses ultrasound waves to create images of structures within the body. It is a non-invasive imaging device.
- Intended Use: The intended use clearly describes imaging various anatomical sites within the body for diagnostic purposes. It does not mention analyzing samples taken from the body.
- Device Description: The description focuses on the ultrasound technology, imaging modes, and probes used to visualize internal structures.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are characteristic of IVD devices.
Therefore, based on the provided information, the DC-N3/DC-N3S Diagnostic Ultrasound System is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DC-N3/DC-N3S Diagnostic Ultrasound System is applicable for adult, pregnant woman, pediatric and neonate. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes.), cephalic (neonatal and adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vascular and urology exams.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
DC-N3/DC-N3S Diagnostic Ultrasound System is a general purpose, mobile. software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Color M-Mode, Free Xros M-Mode, Free Xros CM, Power/Dirpower Mode, TDI Mode, 3D/4D Mode, iScape Mode or the combined mode (i.e. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.5 MHz to 10.0 MHz.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
fetal, abdominal, pediatric, small organ(breast, thyroid, testes.), cephalic (neonatal and adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vascular and urology
Indicated Patient Age Range
adult, pregnant woman, pediatric and neonate
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests:
DC-N3/DC-N3S Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. Non-clinical tests relied on in this premarket notification for a determination of substantial equivalence include testing showing compliance with the following standards:
- AAMI/ANSI ES60601-1: Medical electrical equipment Part 1: General ■ requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- . IEC 60601-2-37: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- IEC 62304: Medical device software Software life cycle processes 해
- 트 IEC 62366: Medical devices - Application of usability engineering to medical devices
- ISO14971: Medical devices - Application of risk management to medical devices
- UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
- I UD 3: Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 1SO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
Clinical Tests:
Not Applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K123503, K103583, K120699, K101236
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
FEB 19 2014
K140030
Page 1 of 4
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:
1. Submitter:
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South. Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Tel: +86 755 8188 5334 Fax: +86 755 2658 2680
Contact Person:
Tan Zhifeng Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Date Prepared: Nov 22, 2013
- Device Name: DC-N3 DC-N3S Diagnostic Ultrasound System
Classification
Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)
3. Device Description:
DC-N3/DC-N3S Diagnostic Ultrasound System is a general purpose, mobile. software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Color M-Mode, Free Xros M-Mode, Free Xros CM, Power/Dirpower Mode, TDI Mode, 3D/4D Mode, iScape Mode or the combined mode (i.e. B/M-Mode). This system is a Track 3 device
Page 1 of 4
1
that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.5 MHz to 10.0 MHz.
4. Intended Use:
The DC-N3/DC-N3S Diagnostic Ultrasound System is applicable for adult, pregnant woman, pediatric and neonate. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes.), cephalic (neonatal and adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vascular and urology exams.
5. Summary of Modifications and Newly Added Features
This submission device is a modification to DC-N3/DC-N3S Diagnostic Ultrasound System previously cleared in K123503.
The following is a brief overview of the modifications and newly added features. Detailed information is found in 006 Device Description of this submission, while section 009 Comparison to Legally Marketed Device includes a discussion of substantial equivalence with the predicate device(s).
- Newly added transducers .
- CB10-4
- P7-3
- L14-6N
- 7L5
- L7-3
- CWSs
- Newly added needle-guided brackets NGB-020
- Newly added software options 해 Smart NT
Smart Bladder
- Other software modifications Add iScape in Power mode Add Smart AC
- . Newly added calculation formulas
- Trace
- Spline
All of the above modifications and newly added features have been compared with the predicate devices. The results show that these modifications and newly added features are substantially equivalent to the predicate devices.
2
6. Comparison with Predicate Devices:
| Predicate
Device | Manufacturer | Model | 510(k)
Number |
|---------------------|--------------|--------------------------------------------|------------------|
| 1 | Mindray | DC-N3/DC-N3S
(Main predicate
device) | K123503 |
| 2 | Mindray | DC-7 | K103583 |
| 3 | Mindray | DC-T6 | K120699 |
| 4 | GE | Voluson E8 | K101236 |
DC-N3/DC-N3S Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
DC-N3/DC-N3S Diagnostic Ultrasound System employs the same technology as the predicate devices. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations. The subject device also has the same intended uses and basic operating modes as the predicate devices.
7. Non-clinical Tests:
DC-N3/DC-N3S Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. Non-clinical tests relied on in this premarket notification for a determination of substantial equivalence include testing showing compliance with the following standards:
- AAMI/ANSI ES60601-1: Medical electrical equipment Part 1: General ■ requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- . IEC 60601-2-37: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- IEC 62304: Medical device software Software life cycle processes 해
- 트 IEC 62366: Medical devices - Application of usability engineering to medical devices
- ISO14971: Medical devices - Application of risk management to medical devices
- UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
- I UD 3: Standard for Real Time Display of Thermal and Mechanical Acoustic Output
Page 3 of 4
3
K140030
Page 4 of 4
Indices on Diagnostic Ultrasound Equipment
- 1SO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
8. Clinical Tests:
Not Applicable.
Conclusion:
Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DC-N3/DC-N3S Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 19, 2014
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313
Re: K140030
Trade/Device Name: DC-N3/DC-N3S Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Il Product Code: IYN, IYO, ITX Dated: February 4, 2014 Received: February 5, 2014
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the DC-N3/DC-N3S Diagnostic Ultrasound System, as described in your premarket notification:
| Transducer Model Number | ||
|---|---|---|
| 3C5A | 6C2 | V10-4 |
| V10-4B | 7L4A | L12-4 |
| L14-6 | 2P2 | D6-2 |
| D6-2A | 6CV1 | 7L5 |
| L7-3 | L14-6N | P7-3 |
| CB10-4 | CW5s |
5
Page 2—Mr. Mark Job
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 80}), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041`or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140030
Device Name
The DC-N3/ DC-N3S Diagnostic Ultrasound System
Indications for Use (Describe)
The DC-N3,DC-N3S Diagnostic Ultrasound System is applicable for adult, pregnant woman, pediatic and neonate. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes.), cephalic (neonatal and adult), trans-vaginal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vascular and urology exams.
Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Page 1 of 20
2-1
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
7
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
t
8
Diagnostic Ultrasound Indications For Use Format
DC-N3/DC-N3S Diagnostic Ultrasound System System:
N/A Transducer:
510(k) Number: K140030
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | P | Note 1, 2,3, 4,6,7 | |
| Abdominal | P | P | P | P | P | P | P | Note 1, 2, 3,4,5,6,7 | |
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | |
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Fetal Imaging & Other | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2, 4,5,6,7 |
| Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | |
| Trans-rectal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Trans-vaginal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Intravascular | |||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | Note 1, 2,4,5.6.7 |
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5.6.7 | |
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | Note 1, 2,4,5,6 | |
| Intra-cardiac | |||||||||
| Peripheral vessel | Peripheral vessel | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 |
| Other (Specify***) | P | P | P | P | P | P | Note 1, 2, 4,6,7 |
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
9
DC-N3/DC-N3S Diagnostic Ultrasound System System: Transducer: 3C5A
510(k) Number: K140030
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Abdominal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Other (Specify***) | |||||||||
| N=new indication: P=previously cleared by FDA-(K123503); E=added under Appendix E | |||||||||
| Additional comments: Combined modes-B+M、PW+B、Color+B、Power+B、PW+Color+ B、Power + PW +B. | |||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | |||||||||
| **Small organ-breast, thyroid, testes. | |||||||||
| ***Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3: 4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note 5: TDI | |||||||||
| Note 6: Color M | |||||||||
| Note 7: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
10
Transducer: 6C2
510(k) Number: K140030
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| I Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Small Organ (Specify**) | |||||||||
| Fetal Imaging & | Neonatal Cephalic | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Other | Adult Cephalic | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Intravascular | |||||||||
| Cardiac Adult | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| vessel | Other (Specify***) | ||||||||
| N=new indication: P=previously cleared by FDA-(K123503): | E=added under Appendix E | ||||||||
| Additional comments: Combined modes--B+M, PW+B, Color + B, Power + B, PW+Color+B, Power + PW +B. | |||||||||
| * Intraoperative includes abdominal, thoracic, and vascular. | |||||||||
| ** Small organ-breast, thyroid, testes. | |||||||||
| *** Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3: 4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note 5: TDI | |||||||||
| Note 6: Color M | |||||||||
| Note 7: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
11
Transducer: V 10-4
510(k) Number: K140030
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| 1 Only) | Specific (Track I & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Fetal Imaging & | Neonatal Cephalic | ||||||||
| Other | Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Trans-vaginal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| vessel | Other (Specify***) | P | P | P | P | P | P | P | Note 1. 2. 4.6.7 |
| N=new indication: P=previously cleared by FDA-(K123503): | E=added under Appendix E | ||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power+PW+B. | |||||||||
| * Intraoperative includes abdominal, thoracic, and vascular. | |||||||||
| ** Small organ-breast, thyroid, testes. | |||||||||
| *** Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3: 4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note 5: TDI | |||||||||
| Note 6: Color M | |||||||||
| Note 7: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) |
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
12
DC-N3/DC-N3S Diagnostic Ultrasound System System:
Transducer: V 10-4B
·
·
1
510(k) Number: K140030
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
|---|
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Fetal Imaging & | |||||||||
| Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Trans-vaginal | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac- | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | ||||||||
| Other (Specify *** ) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| N=new indication: P=previously cleared by FDA-(K123503): E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power + PW +B. | |||||||||
| * Intraoperative includes abdominal, thoracic, and vascular. | |||||||||
| ** Small organ-breast, thyroid. testes. | |||||||||
| *** Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3: 4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note 5: TDI | |||||||||
| Note 6: Color M | |||||||||
| Note 7: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
.
13
DC-N3/DC-N3S Diagnostic Ultrasound System System: Transducer: 7L4A 510(k) Number: K140030
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,6.7 | ||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2, 4,6.7 | ||
| Fetal Imaging & | |||||||||
| Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Other (Specify***) | |||||||||
| N=new indication: P=previously cleared by FDA-(K123503): E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + PW+B. | |||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | |||||||||
| **Small organ-breast, thyroid, testes. | |||||||||
| ***Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3: 4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note 5: TDI | |||||||||
| Note 6: Color M | |||||||||
| Note 7: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
.
14
し | 2-4 Transducer:
.
510(k) Number: K140030
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General (Track | ||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2, 4,6.7 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,6.7 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2, 4,6.7 | |||
| Fetal Imaging & | ||||||||||
| Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Adult Cephalic. | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | Note 1,2, 4,6,7 | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | Note 1,2, 4,6,7 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Other (Specify***) | ||||||||||
| N=new indication: P=previously cleared by FDA-(K123503): E=added under Appendix E | ||||||||||
| Additional comments: Combined modes-B+M、PW+B、Color + B、Power+B、PW+Color+B、Power + PW +B. | ||||||||||
| * Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| ** Small organ-breast, thyroid, testes. | ||||||||||
| *** Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3: 4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General (Track I Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2, 4.6.7 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,6,7 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2, 4,6,7 | |||
| Fetal Imaging & | ||||||||||
| Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | Note 1,2, 4,6,7 | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | Note 1,2, 4,6,7 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Other (Specify***) | ||||||||||
| N=new indication: P=previously cleared by FDA-(K123503); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes-B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW+B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3: 4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General (Track | ||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6.7 | ||
| Small Organ (Specify**) | ||||||||||
| Fetal Imaging & | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Other | Adult Cephalic | P | P | P | P | P | P | P | Note 1. 2.4.5.6.7 | |
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | ||
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | ||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| vessel | Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA-(K123503): | E=added under Appendix E | |||||||||
| Additional comments: Combined modes-B+M. PW+B. Color + B. Power + B. PW+Color+ B. Power + PW +B. | ||||||||||
| * Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| ** Small organ-breast, thyroid, testes. | ||||||||||
| *** Other use includes Urology. | ||||||||||
| Note I: Tissue Harmonic Imaging. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3: 4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
15
DC-N3/DC-N3S Diagnostic Ultrasound System System: Transduccr: L 14-6 510(k) Number: K140030
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
.
16
System: DC-N3/DC-N3S Diagnostic Ultrasound System Transducer: 2P2 510(k) Number: K140030
510(k) Number: K140630
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
·
17
DC-N3/DC-N3S Diagnostic Ultrasound System System: Transducer: D6-2 510(k) Number: K140030
Intended Use: Diagram
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | Note1,2, 3, 4,6 | ||||
| Abdominal | P | P | P | P | P | P | Note1,2, 3, 4.6 | ||||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify**) | |||||||||||
| Fetal Imaging & Neonatal Cephalic | |||||||||||
| Other | Adult Cephalic | ||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal (Conventional) | |||||||||||
| Musculo-skeletal (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | Peripheral vessel | ||||||||||
| vessel | Other (Specify***) | ||||||||||
| N=new indication: P=previously cleared by FDA-(K123503); | E=added under Appendix E | ||||||||||
| Additional comments: Combined modes-B+M、PW+B、Color+B、Power+B、PW+Color+B、Power + PW +B. | |||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | |||||||||||
| **Small organ-breast, thyroid, testes. | |||||||||||
| ***Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3: 4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note 5: TDI | |||||||||||
| Note 6: Color M | |||||||||||
| Note 7: Biopsy Guidance | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General (Track | |||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | Note1,2, 3, 4,6 | ||||
| Abdominal | P | P | P | P | P | P | Note1,2. 3. 4,6 | ||||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify**) | |||||||||||
| Fetal Imaging & | Neonatal Cephalic | ||||||||||
| Other | Adult Cephalic | ||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-csoph. (non-Card.) | |||||||||||
| Musculo-skeletal (Conventional) | |||||||||||
| Musculo-skeletal (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Cardiac | Intravascular (Cardiac) ' | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | Peripheral vessel | ||||||||||
| vessel | Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA-(K123503); | E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power + PW+B. | |||||||||||
| * Intraoperative includes abdominal, thoracic, and vascular. | |||||||||||
| ** Small organ-breast, thyroid, testes. | |||||||||||
| *** Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3: 4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note 5: TDI | |||||||||||
| Note 6: Color M | |||||||||||
| Note 7: Biopsy Guidance | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
18
Transducer: D6-2A
510(k) Number: K140030
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
,
1
:
19
DC-N3/DC-N3S Diagnostic Ultrasound System System:
6CV1 Transducer:
510(k) Number: K140030
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | Note1,2,4,6,7 | ||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Fetal Imaging & | Neonatal Cephalic | ||||||||
| Other | Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | P | Note1,2,4,6,7 | ||
| Trans-vaginal | P | P | P | P | P | P | Note1,2,4,6,7 | ||
| Trans-urcthral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| vessel | Other (Specify***) | P | P | P | P | P | P | Note1,2,4,6,7 | |
| N=new indication: P=previously cleared by FDA-(K123503); E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power+PW+B. | |||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | |||||||||
| **Small organ-breast, thyroid, testes. | |||||||||
| ***Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3: 4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note 5: TDI | |||||||||
| Note 6: Color M | |||||||||
| Note 7: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
20
DC-N3/DC-N3S Diagnostic Ultrasound System System:
Transducer: 7L5
510(k) Number: K140030
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General (Track | ||||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2, 4,6,7 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,6,7 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2, 4,6,7 | |||
| Fetal Imaging & | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1,2, 4,6,7 | |||
| Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | Note 1,2, 4,6,7 | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | Note 1,2, 4.6.7 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| vessel | Other (Specify***) | |||||||||
| N=new indication: P=previously cleared by FDA-(K103583): | E=added under Appendix E | |||||||||
| Additional comments: Combined modes-B+M, PW+B, Color+B, Power+B, PW+Color+B, Power + PW+B. | ||||||||||
| * Intraoperative includes abdominal, thoracic, and vascular | ||||||||||
| ** Small organ-breast, thyroid, testes, | ||||||||||
| *** Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3: 4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
21
Transducer: L7-3
510(k) Number: K140030
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Fetal Imaging & | Neonatal Cephalic | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | Note 1,2, 4.6.7 | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| vessel | Other (Specify***) | ||||||||
| N=new indication: P=previously cleared by FDA-(K103583); | E=added under Appendix E | ||||||||
| Additional comments: Combined modes-B+M、PW+B、Color + B、Power + B、PW +Color+ B、 | Power + PW +B . | ||||||||
| * Intraoperative includes abdominal, thoracic, and vascular | |||||||||
| ** Small organ-breast, thyroid, testes, | |||||||||
| ** * Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3: 4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note 5: TDI | |||||||||
| Note 6: Color M | |||||||||
| Note 7: Biopsy Guidance |
Page 16 of 20
22
DC-N3/DC-N3S Diagnostic Ultrasound System System:
L 14-6N Transducer:
510(k) Number: K140030
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Fetal Imaging & | Neonatal Cephalic | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | Note 1,2. 4,6,7 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | Note 1,2. 4,6.7 | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | Note 1,2, 4.6,7 | |
| vessel | Other (Specify***) | ||||||||
| N=new indication: P=previously cleared by FDA-(K103583); E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+ B、Power + PW +B. | |||||||||
| * Intraoperative includes abdominal, thoracic, and vascular | |||||||||
| ** Small organ-breast, thyroid, testes, | |||||||||
| *** Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3:4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note 5: TDI | |||||||||
| Note 6: Color M | |||||||||
| Note 7: Biopsy-Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
23
.
DC-N3/DC-N3S Diagnostic Ultrasound System System:
Transducer: P7-3
510(k) Number: K140030
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track I Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | P | Note 1, 2,4,5.6 | |
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6 | |
| Small Organ (Specify**) | |||||||||
| Fetal Imaging & | |||||||||
| Other | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,5.6 |
| Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,5.6 | |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | P | Note 1, 2,4,5,6 | |
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P | P | P | P | P | P | P | Note 1, 2,4,5,6 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6 |
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | ||||||||
| Other (Specify***) | |||||||||
| N=new indication: P=previously cleared by FDA-(K103583): E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW+B. | |||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | |||||||||
| **Small organ-breast, thyroid, testes, | |||||||||
| ***Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3: 4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note 5: TDI | |||||||||
| Note 6: Color M | |||||||||
| Note 7: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
.
24
CB10-4 Transducer:
510(k) Number: K140030
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Fetal Imaging & | |||||||||
| Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Trans-vaginal | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | ||||||||
| Other (Specify***) | |||||||||
| N=new indication: P=previously cleared by FDA-(K103583); E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M, PW+B, Color + B, Power + B, PW+Color+B, Power+ PW+B, | |||||||||
| * Intraoperative includes abdominal, thoracic, and vascular | |||||||||
| ** Small organ-breast, thyroid, testes, | |||||||||
| *** Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3: 4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note 5: TDI | |||||||||
| Note 6: Color M | |||||||||
| Note 7: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) |
25
| Transducer: | CW5s | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 510(k) Number: K140030 | |||||||||
| Intended Use: | Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | ||||||||
| General (Track | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | ||||||||
| Small Organ (Specify**) | |||||||||
| Fetal Imaging & Neonatal Cephalic | |||||||||
| Other | Adult Cephalic | P | |||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P | ||||||||
| Cardiac Pediatric | P | ||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| vessel | Other (Specify***) | ||||||||
| N=new indication: P=previously cleared by FDA-(K120699): | E=added under Appendix E | ||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+ B、Power + PW +B, | |||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | |||||||||
| ** Small organ-breast, thyroid, testes. | |||||||||
| ***Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3: 4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note 5: TDI | |||||||||
| Note 6: Color M | |||||||||
| Note 7: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
System: DC-N3/DC-N3S Diagnostic Ultrasound System
Page 20 of 20