(30 days)
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, superficial), cardiac(Adult and Pediatric), Peripheral Vascular and urology exams.
DC-N3/DC-N3S is a mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PW, CW, Color, Power, HPRF, TVI, TEI,TVD, Free Xros M/ Free Xros CM, Smart 3D, 4D, iScape, or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).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.
The provided 510(k) summary for the Mindray DC-N3/DC-N3S Diagnostic Ultrasound System does not include a study to prove acceptance criteria for device performance. Instead, it states that the system has been evaluated for various safety and performance aspects and found to conform with applicable medical safety standards, establishing substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or detailed device performance metrics in a tabular format for clinical efficacy. It only broadly states that the device conforms to various safety standards. Therefore, an acceptance criteria table from this document cannot be created as requested.
2. Sample Size Used for the Test Set and Data Provenance:
No specific clinical test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) is described in relation to evaluating the performance of the device's diagnostic capabilities. The submission focuses on substantial equivalence based on technical characteristics and safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
As there is no described clinical efficacy study with a test set, there is no mention of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned, as no specific clinical test set and ground truth establishment process are detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention any MRMC comparative effectiveness study where human readers' improvement with AI vs. without AI assistance was evaluated. The device is a diagnostic ultrasound system, and the submission's focus is on its technical safety and equivalence rather than an AI-driven diagnostic aid.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No standalone (algorithm only) performance study is described. The device is a complete ultrasound system, not an algorithm being evaluated independently.
7. Type of Ground Truth Used:
No specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned as there is no detailed clinical efficacy study described for establishing diagnostic performance. The evaluation focuses on conformance to technical and safety standards.
8. Sample Size for the Training Set:
There is no mention of a training set or its sample size, as the document describes a diagnostic ultrasound system, not an AI/ML-driven device that typically undergoes a training phase.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as no training set is described in the document.
{0}------------------------------------------------
510(K) SUMMARY
DEC 1 3 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).
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 5635 Fax: +86 755 2658 2680
Contact Person:
Bai Yanhong 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: September 7, 2012
2. 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 (90-IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)
3. Device Description:
DC-N3/DC-N3S is a mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PW, CW, Color, Power, HPRF, TVI, TEI,TVD, Free Xros M/ Free Xros CM, Smart 3D, 4D, iScape, or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased
Image /page/0/Figure/20 description: The image shows the number 05-1 in bold black font. The number 05 is followed by a hyphen and then the number 1. The background is white.
{1}------------------------------------------------
array with a frequency range of approximately 2.5 MHz to 10.0 MHz.
4. Intended Use:
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, superficial), cardiac(Adult and Pediatric), Peripheral Vascular and urology exams.
5. Comparison with Predicate Devices:
| PredicateDevice | Manufacturer | Model | 510(k) Control Number |
|---|---|---|---|
| 1 | Mindray | DC-7 | K103583 |
| 2 | Mindray | DC-T6 | K120699 |
| 3 | Mindray | DC-8 | K113647 |
| 4 | Mindray | Z6 | K122010 |
DC-N3/DC-N3S Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate devices.
6. 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. This device has been designed to meet the following standards: UD 2. UD 3. IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37,UL 60601-1, ISO14971 and ISO 10993-1.
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
Image /page/1/Figure/11 description: The image shows the number "05-2" in a bold, sans-serif font. The numbers and hyphen are all in black. The background is white.
{2}------------------------------------------------
substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
.
:
.
.
.
05-3
:
:
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 13, 2012
Shenzhen Mindray Bio-Medical Electronics., Ltd. . % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709
3C5A 6C2 V10-4 V10-4B 7L4A L12-4
Re: K123503
Trade/Device Name: The DC-N3/DC-N3S Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: October 31, 2012 Received: November 13, 2012
Dear Mr. Rongero:
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 The DC-N3/DC-N3S Diagnostic Ultrasound System as described in your premarket notification:
Transducer Model Number
| L14-6 | |
|---|---|
| 2P2 | |
| D6-2 | |
| D6-2A | |
| 6CV1 |
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
{4}------------------------------------------------
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/ReportalProblem/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 Lauren Hefner at (301) 796-6881.
Sincerely Yours.
Janine M. Morris -S
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure(s)
{5}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: The DC-N3/ DC-N3S Diagnostic Ultrasound System
Indications for Use:
The DC-N3/ DC-N3S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. 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.
Over – The – Counter Use AND/OR Prescription Use X (21 CFR Part 807 Subpart C) (21 CFR Part 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic and Radiological Health (OIR)
ivision of Rediolor
Office of In Vitro Diagnostics
510(k) K123503
OS-1
{6}------------------------------------------------
Transducer
and the same of the same of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the st
System Model:
DC-N3
×
.
510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | Amplitudee Doppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | N | Note1,2, 3, 4,6,7 |
| Abdominal | N | N | N | N | N | N | N | Note1,2, 3, 4,5,6,7 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,5,6,7 |
| Small organ(specify)** | N | N | N | N | N | N | N | Note1, 2, 4,6,7 |
| Neonatal Cephalic | N | N | N | N | N | N | N | Note1, 2, 4,5,6,7 |
| Adult Cephalic | N | N | N | N | N | N | N | Note1, 2, 4,5,6,7 |
| Trans-rectal | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
| Trans-vaginal | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
| Intravascular | ||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1,2,5,6,7 |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,2,5,6,7 |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
| Other (specify)*** | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
| N=new indication; P=previously cleared by FDA; 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 etc. | ||||||||
| **Small organ-breast, thyroid, testes, etc. | ||||||||
| ***Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | ||||||||
| Note 3:4D(Real-time 3D) | ||||||||
| Note 4: iScape | ||||||||
| Note5: TDI | ||||||||
| Note6: Color M | ||||||||
| Note7: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||
| Prescription USE (Per 21 CFR 801.109) |
Biriston of Radiolog
510(k)
08-2
{7}------------------------------------------------
| System | Transducer | X | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Model: | 3C5A | |||||||||
| 510(k) Number(s) | ||||||||||
| Mode of Operation | ||||||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler | Amplitude Doppler | Combined(specify) | Other (specify) | ||
| Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Abdominal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Intraoperative (specify)* | ||||||||||
| Intraoperative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Small organ(specify)** | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph (non-Card.) | ||||||||||
| Musculo-skeletal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Musculo-skeletal Superficial | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph.(Cardiac) | ||||||||||
| Intra-Cardiac | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Other (specify) *** | ||||||||||
| N=new indication; P=previously cleared by FDA; 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 etc. | ||||||||||
| ** Small organ-breast, thyroid, testes, etc. | ||||||||||
| ** * Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
ID+
Prescription USE (Per 21 CFR 801.109)
ン... ・
510(k) K123503
08-3
{8}------------------------------------------------
6C2
×
System Model:
510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | Amplitudee Doppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Intravascular | ||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Other (specify) *** | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, PW +Color+B, Power + PW+B. | ||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||
| ** Small organ-breast, thyroid, testes, etc. | ||||||||
| *** Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | ||||||||
| Note 3:4D(Real-time 3D) | ||||||||
| Note 4: iScape | ||||||||
| Note5: TDI | ||||||||
| Note6: Color M | ||||||||
| Note7: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Mode of Operation | ||||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Trans-vaginal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify)*** | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| N=new indication; P=previously cleared by FDA; 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 etc. | ||||||||
| ** Small organ-breast, thyroid, testes, etc. | ||||||||
| *** Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | ||||||||
| Note 3:4D(Real-time 3D) | ||||||||
| Note 4: iScape | ||||||||
| Note5: TDI | ||||||||
| Note6: Color M | ||||||||
| Note7: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
Concurrence of CDRH, Office of Device Evaluation(QDE)
Prescription USE (Per 21 CFR 801.109)
(Division Sign Off)
Division of Radiological Health
510(k)
08-4
{9}------------------------------------------------
V 10-4
Transducer
×
System Mođel:
510(k) Number(s)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 80 1000
CFR 801(f)(9)
(Division Sign Off)
Division of Radiological Health
510(k) K123503
{10}------------------------------------------------
| System | Transducer | X | |
|---|---|---|---|
| Model: | V10-4B | ||
| 510(k) Number(s) |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |
| Trans-vaginal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify) *** | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
N=new indication; P=previously cleared by FDA; 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 etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(QDE)
Prescription USE (Per 21 CFR 801.189)
.
・
(Division Sign Off)
Division of Radiological Health
510(k) K123503
08-6
{11}------------------------------------------------
| Model: | 7L4A | |||||||
|---|---|---|---|---|---|---|---|---|
| 510(k) Number(s) | ||||||||
| Mode of Operation | ||||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | Note 1,2, 4,6,7 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | Note 1,2, 4,6,7 | |
| Small organ(specify)** | N | N | N | N | N | N | Note 1,2, 4,6,7 | |
| Neonatal Cephalic | N | N | N | N | N | N | Note 1,2, 4,6,7 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | N | N | N | N | N | N | Note 1,2, 4,6,7 | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | Note 1,2, 4,6,7 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | N | N | N | Note 1,2, 4,6,7 | |
| Other (specify)*** | ||||||||
| N=new indication; P=previously cleared by FDA; 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 etc. | ||||||||
| ** Small organ-breast, thyroid, testes, etc. | ||||||||
| *** Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | ||||||||
| Note 3:4D(Real-time 3D) | ||||||||
| Note 4: iScape | ||||||||
| NoteS: TDI | ||||||||
| Note6: Color M | ||||||||
| Note7: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
Transducer
×
System
(Division Sign Off)
Prescription USE (Per 21 CFR 801.109)
Division of Rastiblogical Health
afte
Office of In Vitro Diagnostics and Radiological Health
510(k) K123503
1
{12}------------------------------------------------
L12-4
x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x
System Model:
·
510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Small organ(specify)** | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Other (specify)*** |
(Division Sign Off) Division of Radiological Health
510(k) K123503
08-8
{13}------------------------------------------------
L 14-6
Transducer
.
×
System Model:
510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | Amplitudee Doppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Small organ(specify)** | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Other (specify)*** | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, PW +Color+B, Power + PW +B. | ||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||
| ** Small organ-breast, thyroid, testes, etc. | ||||||||
| *** Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | ||||||||
| Note 3:4D(Real-time 3D) | ||||||||
| Note 4: iScape | ||||||||
| Note5: TDI | ||||||||
| Note6: Color MNote7: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||
| Prescription USE (Per 21 CFR 801.109) | (Division Sign Off) | |||||||
| Mode of Operation | ||||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler | Amplitudee Doppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2,4,5,6,7 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2,4,5,6,7 |
| Small organ(specify) ** | ||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2,4,5,6,7 |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2,4,5,6,7 |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2,4,5,6,7 |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify) *** | ||||||||
| N=new indication; P=previously cleared by FDA; 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 etc. | ||||||||
| ** Small organ-breast, thyroid, testes, etc. | ||||||||
| *** Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | ||||||||
| Note 3:4D(Real-time 3D) | ||||||||
| Note 4: iScape | ||||||||
| Note5: TDI | ||||||||
| Note6: Color M | ||||||||
| Note7: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
Division of Radlological Health
510(k) K123503
{14}------------------------------------------------
2P2
×
System Model:
510(k) Number(s)
Prescription USE (Per 21 CFR 801.109)
(.109)
(Division Sign Off)
Division of Radiological Health
510(k) K123503
08-10
{15}------------------------------------------------
| System | Transducer | X | |
|---|---|---|---|
| Model: | D6-2 | ||
| 510(k) Number(s) |
Mode of Operation
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | N | Note 1,2, 3, 4,6 |
| Abdominal | N | N | N | N | N | N | N | Note 1,2, 3, 4,6 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify)*** |
N=new indication; P=previously cleared by FDA; 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 etc.
**Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
Division Sign Off
Division of Radiological Health
510(k) 123503
08-11
{16}------------------------------------------------
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note1,2, 3, 4, | |
| Abdominal | N | N | N | N | N | N | Note1,2, 3, 4, | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify) *** | ||||||||
| N=new indication; P=previously cleared by FDA; 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 etc. | ||||||||
| ** Small organ-breast, thyroid, testes, etc. | ||||||||
| *** Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | ||||||||
| Note 3:4D(Real-time 3D) | ||||||||
| Note 4: iScape | ||||||||
| Note5: TDI | ||||||||
| Note6: Color M |
System
Transducer
×
Bivision of Aadiological Health
Prescription USE (Per 21 CFR 801.109)
Office of In Vitro Diagnostics and Radiological Health
(Division Sign Off),
in
510(k) K123503
08-12
{17}------------------------------------------------
| System | |
|---|---|
| Model: | 6CV1 |
| Transducer | X |
| 510(k) Number(s) |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note 1,2, 4,6,7 | |
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | N | Note1,2, 4,6,7 | |
| Trans-vaginal | N | N | N | N | N | N | Note1,2, 4,6,7 | |
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify)*** | N | N | N | N | N | N | Note1,2, 4,6,7 |
N=new indication; P=previously cleared by FDA; 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 etc.
**Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
(Division Sign Off)
Division of Radiological Health
1
- 1
Office of In Vitro Diagnostics and Radiological Health
510(k) K123503 08-13
Diagnostic Ultrasound Indications for Use Form
§ 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.