(75 days)
No
The document describes a standard ultrasound system with various imaging modes and post-processing capabilities, but there is no mention of AI or ML technology. The lack of information regarding training/test sets and performance metrics typically associated with AI/ML devices further supports this conclusion.
No.
The device is described as a "Diagnostic Ultrasound System" and its intended use is to "acquire and display ultrasound data" to "generate onscreen display of anatomic structures and fluid flow within the body," indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" explicitly states: "The DC-N2/DC-N2S Diagnostic Ultrasound System is applicable for adults... It is intended for use in fetal, abdominal... and urology exams." Additionally, the "Device Description" section states: "DC-N2/DC-N2S is a software controlled, ultrasonic diagnostic system." These statements clearly indicate the device's diagnostic purpose.
No
The device description explicitly states it is an "ultrasonic diagnostic system" and employs "an array of probes," which are hardware components essential for acquiring ultrasound data. While it is software-controlled and performs image processing, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The description clearly states that this is an "ultrasonic diagnostic system" that "acquire and display ultrasound data" and "generate onscreen display of anatomic structures and fluid flow within the body." This indicates it's used for imaging within the body, not for testing samples from the body.
- The intended use lists various anatomical sites for imaging. These are all locations within the body, consistent with an ultrasound system.
- There is no mention of analyzing biological samples. The description focuses on acquiring and processing ultrasound echoes.
Therefore, the DC-N2/DC-N2S Diagnostic Ultrasound System is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DC-N2/DC-N2S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid and testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult and pediatric), peripheral vascular and urology exams.
Product codes
IYN, IYO, ITX
Device Description
DC-N2/DC-N2S is asoftware controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PW, Color, Power , iScape, Smart 3D 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 and convex array with a frequency range of approximately 3.5 MHz to 10.0 MHz.
Mentions image processing
All systems transmit ultrasonic energy into patients, perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (conventional, superficial), Cardiac (adult and pediatric), Peripheral Vascular, Urology
Indicated Patient Age Range
adults, pregnant women, pediatric and neonates
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
Not applicable. The subject of this submission, DC-N2/DC-N2S Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KI32779
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(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 5658 Fax: +86 755 2658 2680
Contact Person:
Wu Zicui 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: July 19, 2013
- Device Name: DC-N2/DC-N2S 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-N2/DC-N2S is asoftware controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PW, Color, Power , iScape, Smart 3D 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 and convex array with a frequency range of approximately 3.5 MHz to 10.0 MHz.
1
4. Intended Use:
The DC-N2/DC-N2S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid and testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult and pediatric), peripheral vascular and urology exams.
5. Comparison with Predicate Devices:
DC-N2/DC-N2S Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
| Predicate
Device | Manufacturer | Model | 510(k)
Number | Control |
|---------------------|--------------|---------|------------------|---------|
| 1 | Mindray | Z5 | K130695 | |
| 2 | Mindray | DC-N3 | K123503 | |
| 3 | Mindray | Logiq e | K113690 | |
DC-N2/DC-N2S has 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. All systems transmit ultrasonic energy into patients, 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.
6. Non-clinical Tests:
DC-N2/DC-N2S 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 designed to conform with applicable medical safety standards. This device has been tested and evaluated under the following standards:
- 0 UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
- 태 UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 트 AAMI / ANSI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- 년 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 (Edition 3)
- 그 IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and
2
monitoring equipment
..............................................................................................................................................................................
- 포 ISO14971 Medical devices - Application of risk management to medical devices
- Biological evaluation of medical devices -- Part 1: Evaluation and ISO 10993-1 . testing within a risk management process
- n Medical devices - Application of usability engineering to medical IEC 62366 devices
- Medical device software Software life cycle processes IEC 62304
These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.
7. Clinical Studies
Not applicable. The subject of this submission, DC-N2/DC-N2S Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
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-N2/DC-N2S Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features the HHS symbol, which consists of a stylized caduceus-like design with three overlapping shapes resembling human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2013
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K132779
Trade/Device Name: DC-N2/DC-N2S Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 4, 2013 Received: November 5, 2013
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. Ilisting 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-N2/DC-N2S Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 35C50EA | 65EC10EA |
|---|---|
| 65EC10ED | 75L38EA |
| 65C15EA | 35C20EA |
| 10L24EA | 65EB10EA |
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
4
Page 2-Mr. Job
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 801), 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/ReportalProblem/default.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/Industry/default.htm.
Sincerely vours,
Sm.7).
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K132779
Device Name: The DC-N2/DC-N2S Diagnostic Ultrasound System
Indications for Use:
The DC-N2/DC-N2S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, musculo-skeletal(conventional, trans-vaginal, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams.
Prescription Use X X AND/OR Over - The - Counter Use (21 CFR Part 801 Subpart D) (21 CFR Part 807 Subpart C)
(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)
San in Ja)
(Division Sign-Off) Division of Radiological Health Office of In I'itro Diagnostics and Radiological Health
K132779 510(k)
6
Transducer System × DC-N2/DC-N2S Model: 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 | N | Note 1.2.3.4 |
| Abdominal | N | N | N | N | N | N | N | Note 1.2.3.4 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1.2.3.4 |
| Small organ(specify)** | N | N | N | N | N | N | N | Note 1.2.3.4 |
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1.2.3.4 |
| Adult Cephalic | N | N | N | N | N | N | N | Note 1.2.3.4 |
| Trans-rectal | N | N | N | N | N | N | N | Note 1.2.3.4 |
| Trans-vaginal | N | N | N | N | N | N | N | Note 1.2.3.4 |
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | N | N | N | N | N | N | N | Note 1.2.3.4 |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | Note 1.2.3.4 |
| Intravascular | ||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1.2.3.4 |
| Cardiac Pediatric | N | N | N | N | N | N. | N | Note 1,2,3,4 |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral vessel | N | N | N | N | N | N | N | Note 1,2,3,4 |
| Other (specify)*** | N | N | N | N | N | N | N | Note 1.2.3.4 |
Additional comments:Combined modes: B+M. PW+B. Color + B. PW +Color+ 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. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
7
Transducer
Model: 510(k) Number(s)
System
Transducer × 35C50EA
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | Note 1.2.3.4 | |
| Abdominal | P | P | P | P | P | P | Note 1.2.3.4 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | Note 1.2.3.4 | |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | P | P | P | P | P | P | Note 1.2.3.4 | |
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral vessel | P | P | P | P | P | P | Note 1.2.3.4 | |
| Other (specify)*** | ||||||||
| N=new indication: P=previously cleared by FDA(K130695); 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. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape :
Note 4: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
8
| System | Transducer | x | |
|---|---|---|---|
| Model: | 65EC10EA | ||
| 510(k) Number(s) |
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | Amplitud | |||
| Doppler e Doppier | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | Note 1 .2.3,4 | ||
| Abdominal | |||||||||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small organ(specify)** | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | b | P | P | P | p | Note 1 .2.3.4 | ||
| Trans-vaginal | િ | P | P | ្រ | P | b | Note I .2.3.4 | ||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal Superficial | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral vessel | |||||||||
| Other (specify) ** * | P | P | p | P | P | P | Note I .2.3.4 | ||
| N=new indication: P=previously cleared by FDA(K130695): E=added under Appendix E | |||||||||
| Additional comments:Combined modes: B+M. PW+B. Color + B. PW +Color+ 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. The feature does not use contrast agents. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3: iScape | |||||||||
| Nota 1, Dispor Cuidance | |||||||||
| Mode of Operation . | |||||||||
| Clinical Application | B | M | PWD | CWD | Color | ||||
| Doppler | e Doppler | Amplitud Combined | |||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | Note 1.2.3.4 | ||
| Abdominal | |||||||||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small organ(specify)** | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | Note 1 .2.3.4 | ||
| Trans-vaginal | N | N | N | N | N | N | Note 1.2.3.4 | ||
| Trans-urcthral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal Superficial | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral vessel | |||||||||
| Other (specify) ** * | N | N | N | N | N | પ | Note 1.2.3.4 | ||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments:Combined modes: B+M, PW+B, Color + B, PW +Color+ 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. The feature does not use contrast agents. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3: iScape | |||||||||
| Mode of Operation | |||||||||
| Clinical Application | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2,3,4 | ||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2,3,4 | ||
| Small organ(specify)** | P | P | P | P | P | P | Note 1,2,3,4 | ||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1.2.3.4 | ||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| Conventional | P | P | P | P | P | P | Note 1.2.3.4 | ||
| Musculo-skeletal Superficial | P | P | P | P | P | P | Note 1.2.3.4 | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral vessel | P | P | P | P | P | P | Note 1.2.3.4 | ||
| Other (specify)*** | |||||||||
| N=new indication; P=previously cleared by FDA(K130695); 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. The feature does not use contrast agents. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3: iScape | |||||||||
| Note 4: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||
| Mode of Operation | |||||||||
| Clinical Application | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude Doppler | Combined | |||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | Note 1.2.3.4 | ||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note 1.2.3.4 | ||
| Small organ(specify)** | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1.2.3.4 | ||
| Adult Cephalic | P | P | P | P | P | P | Note 1.2.3.4 | ||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal Superficial | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral vessel | |||||||||
| Other (specify) ** * | |||||||||
| N=new indication; P=previously cleared by FDA(K130695); 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. The feature does not use contrast agents. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3: iScape | |||||||||
| Note 4: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
Note 4: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
9
×
System
Transducer
65ECI0ED
Model:
510(k) Number(s)
Note 4: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
10
75L38EA
System Model:
Transducer x
.
Model:
510(k) Number(s)
11
65C15EA
Transducer
X
System Model:
510(k) Number(s)
Prescription USE (Per 21 CFR 801.109)
.
12
| System | Transducer | × | |
|---|---|---|---|
| Model: | 35C20EA | ||
| 510(k) Number(s) |
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2,3,4 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2,3,4 | |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| 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 | Note 1,2,3,4 | |
| Cardiac Pediatric | P | P | P | P | P | P | Note 1,2,3,4 | |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral vessel | ||||||||
| Other (specify)*** |
N=new indication; P=previously cleared by FDA(K130695); 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. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
13
Prescription USE (Per 21 CFR 801.109)
Diagnostic Ultrasound Indications for Use Form
| System | |
|---|---|
| Model: | 10L24EA |
| 510(k) Number(s) |
| Transducer | X |
|---|---|
| ------------ | --- |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic |
| Doppler | e Doppler | (specify) | ||||
|---|---|---|---|---|---|---|
| Ophthalmic | ||||||
| Fetal | ||||||
| Abdominal | P | P | P | P | P | Note 1.2.3.4 |
| Intraoperative (specify)* | ||||||
| Intraoperative (Neuro) | ||||||
| Laparoscopic | ||||||
| Pediatric | P | P | P | P | P | Note 1.2.3.4 |
| Small organ(specify)** | P | P | P | P | P | Note 1.2.3.4 |
| Neonatal Cephalic | P | P | P | P | P | Note 1.2.3.4 |
| Adult Cephalic | ||||||
| Trans-rectal | ||||||
| Trans-vaginal | ||||||
| Trans-urethral | ||||||
| Trans-esoph.(non-Card.) | ||||||
| Musculo-skeletal | ||||||
| Conventional | P | P | P | P | P | Note 1.2.3.4 |
| Musculo-skeletal Superficial | P | P | P | P | P | Note 1.2.3.4 |
| Intravascular | ||||||
| Cardiac Adult | ||||||
| Cardiac Pediatric | ||||||
| Intravascular (Cardiac) | ||||||
| Trans-esoph.(Cardiac) | ||||||
| Intra-Cardiac | ||||||
| Peripheral vessel | P | P | P | P | P | Note 1.2.3.4 |
| Other (specify)*** | ||||||
| N=new indication; P=previously cleared by FDA(K130695); 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. The feature does not use contrast agents. | ||||||
| Note 2: Smart3D | ||||||
| Note 3: iScape | ||||||
| Note 4: |
Note 4: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
14
Prescription USE (Per 21 CFR 801.109)
| System | Transducer | X | |
|---|---|---|---|
| Model: | 65EB10EA | ||
| 510(k) Number(s) |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | |
| Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | Note 1.2.3.4 | ||
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | N | Note 1.2.3.4 | |
| Trans-vaginal | N | N | N | N | N | N | Note 1.2.3.4 | |
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral vessel | ||||||||
| Other (specify)*** | N | N | N | N | N | N | Note 1.2.3.4 |
N=new indication: P=previously cleared by FDA: E=added under Appendix E
Additional comments:Combined modes: B+M. PW+B. Color - B. PW -Color+ 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. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Diagnostic Ultrasound Indications for Use Form
Prescription USE (Per 21 CFR 801.109)
·
15
(Division Sign-Off) Division of Radiological Health Office of In Fitro Diagnostics and Radiological Health
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:
510(k)
.
.
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