(11 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound functionalities.
No
The device is described as a "Diagnostic Ultrasound System" for acquiring and displaying ultrasound images across various anatomical sites, indicating its purpose is for diagnosis, not therapy.
Yes
The name of the device itself "Z6 Diagnostic Ultrasound System" and its stated "Intended Use / Indications for Use" directly specify its diagnostic purpose for various medical exams.
No
The device description explicitly states it is a "software controlled, ultrasound diagnostic system" and mentions employing "an array of probes," which are hardware components essential for ultrasound imaging. The performance studies also include evaluations of acoustic output, biocompatibility, and electrical/mechanical safety, all related to hardware.
Based on the provided information, the Z6 Diagnostic Ultrasound System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Z6 Diagnostic Ultrasound System is described as a "general purpose, portable, software controlled, ultrasound diagnostic system." Its function is to acquire and display ultrasound images.
- Modality: The input imaging modality is Ultrasound, which is an in-vivo imaging technique (imaging within the living body), not an in-vitro technique (imaging outside the living body).
- Intended Use: The intended use describes imaging various anatomical sites within the body for diagnostic purposes.
The device is clearly designed for imaging the internal structures of the body using ultrasound waves, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Z6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic. trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial). cardiac(adult, pediatric), peripheral vessel and urology exams.
Product codes
IYN, IYO, ITX
Device Description
Z6 Diagnostic Ultrasound System is a general purpose, portable, 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, Power/Dirpower 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, abdominal, thoracic, vascular, pediatric, breast, thyroid, testes, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional, superficial), cardiac, peripheral vessel, urology.
Indicated Patient Age Range
Adults, pregnant women, pediatric patients, 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
Non-clinical Tests: Z6 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: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, IEC 62304, IEC 62366, UL 60601-1, ISO14971, UD 2, UD 3 and ISO 10993-1.
Key Metrics
Not Found
Predicate Device(s)
K102991, K083001, K100830, K103583, K090912
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
510(K) SUMMARY
JUL 20 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 5604 Fax: +86 755 2658 2680
Contact Person:
Zhai Pei
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: June 15, 2012
2. Device Name: Z6 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 (90-1YO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-1TX)
3. Device Description:
Z6 Diagnostic Ultrasound System is a general purpose, portable, 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, Power/Dirpower 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.
1
4. Intended Use:
The Z6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic. trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial). cardiac(adult, pediatric), peripheral vessel and urology exams.
5. Comparison with Predicate Devices:
Z6 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
| Predicate
| Device | Manufacturer | Model | 510(k) Control Number |
|---|---|---|---|
| 1 | Mindray | M5 | K102991,K083001 |
| 2 | Mindray | M7 | K100830 |
| 3 | Mindray | DC-7 | K103583 |
| 4 | Mindray | DP-6900 | K090912 |
They have the similar 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:
Z6 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: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, IEC 62304, IEC 62366,UL 60601-1, ISO14971, UD 2, UD 3 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 Z6 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market. ﻨﭧ J.b ..........
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is in a simple, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Jeff D. Rongero Senior Project Manager UL LLC 12 Laboratory Drive RESEARCH TRIANGLE PARK NC 27709
Re: K122010
Trade/Device Name: Z6 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: June 29, 2012 Received: July 9, 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 Z6 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 3C5P | CB10-4P |
|---|---|
| 6C2P | V10-4BP |
| 6CV1P | 7LT4P |
| 7L4P | 6LE7P |
| 7L5P | 2P2P |
| L14-6P |
JUL 2 0 2012
3
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Jeffrey Ballyns at (301) 796-6105.
Sincerely Yours.
Richard D. Kuhn
Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known):
Device Name: Z6 Diagnostic Ultrasound System
Indications For Use:
The Z6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It's intended for use in fetal, abdominal, intraoperative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, transvaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel and urology exams.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign Off)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K122010
Page 1 of
5
×
mindray迈瑞
Diagnostic Ultrasound Indications for Use Form · Transducer
- System . Model: 510(k) Number(s)
Z6 Diagnostic Ultrasound System
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note 1,2 | |
| Abdominal | N | N | N | N | N | N | N | Note 1,2 |
| Intraoperative (specify)* | N | N | N | N | N | N | N | Note 1,2 |
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2 |
| Small organ(specify)** | N | N | N | N | N | N | Note 1,2 | |
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2 |
| Adult Cephalic | N | N | N | N | N | N | Note1, 2 | |
| Trans-rectal | N | N | N | N | N | N | Note 1. 2 | |
| Trans-vaginal | N | N | N | N | N | N | Note 1, 2 | |
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | N | N | N | N | N | N | Note 1,2 | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | Note 1,2 | |
| Intravascular | ||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1,2 |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,2 |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | N | N | N | N | N | N | Note1, 2 | |
| Other (specify)*** | N | N | N | N | N | N | Note 1, 2 | |
| 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, Color+B+PW, Power+B+PW |
*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: 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 Devices Office of in Vitro Diagno aluation and Safety
K1220010
510K.
6
Mindray Co.,LTD.-Z6 Diagnostic Ultrasound System
Diagnostic Ultrasound Indications for Use Form
| System | Transducer | X | |
|---|---|---|---|
| Model: | 3C5P | ||
| 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 | |
| Abdominal | N | N | N | N | N | N | Note 1, 2 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | Note 1, 2 | |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | N | N | N | N | N | N | Note 1, 2 | |
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | N | N | N | N | N | N | Note 1, 2 | |
| 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, Color+B+PW, Power+B+PW
*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: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription USE (Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Marl D'Aun
(Division Sign-Off) Division of Radiological Devices Office of In Vita ro Diagnostic Device Evaluation and Safety
7
Mindray Co.,LTD.-Z.6 Diagnostic Ultrasound System
.
Diagnostic Ultrasound Indications for Use Form
| Transducer | × 6C2P |
|---|---|
| ------------ | -------- |
Model: 510(k) Number(s) .
. . .
.
System
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2 |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2 |
| Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2 |
| 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; E=added under Appendix E | ||||||||
| Additional comments:Combined modes: B+M, PW+B, Color+B, Power+B, Color+B+PW, Power+B+PW | ||||||||
| * 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: 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
/ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Kia2010
510K
008-4
8
Mindray Co.,LTD .- Z6 Diagnostic Ultrasound System
Diagnostic Ultrasound Indications for Use Form
| System | |
|---|---|
| Model: | 6CV1P |
| 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 | |
| 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 | |
| Trans-vaginal | N | N | N | N | N | N | Note 1. 2 | |
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac |
**Small organ-breast, thyroid, testes ***Other use includes Urology.
N
*Intraoperative includes abdominal, thoracic, and vascular
N=new indication; P=previously cleared by FDA; E=added under Appendix E
N
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
N
N
N
Note 2: Biopsy Guidance
Peripheral Vessel
Other (specify)***
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation(ODE)
Additional comments:Combined modes: B+M, PW+B, Color+B, Color+B+PW, Power+B+PW
Prescription USE (Per 21 CFR 801.109)
(Division Sign Off)
(Division Sign-Off) Division of Radiological Devices nostic Device Evaluation and Safety Office of In રાપ્ય
Note 1, 2
N
9
Mindray Co.,LTD.,Z6 Diagnostic_Ultrasound System __
Diagnostic Ultrasound Indications for Use Form
7L4P
Transducer
×
System Model:
510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | Note 1,2 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | Note 1,2 | |
| Small organ(specify)** | N | N | N | N | N | N | Note 1,2 | |
| Neonatal Cephalic | N | N | N | N | N | N | Note 1,2 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | N | N | N | N | N | N | Note 1,2 | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | Note 1,2 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | N | N | N | N | N | N | Note 1,2 | |
| 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, Color+B+PW, Power+B+PW | ||||||||
| * 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: 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)
Signature
(Division Sign-Off) Division of Radiological Devices Office of In Virg Diagnostic Device Evaluation and Safety
ice of In Vitro Diagnostic Device Evaluation and Safe
Klaa010
510K
10
Mindray Co.,LTD.-Z6 Diagnostic Ultrasound System
Diagnostic Ultrasound Indications for Use Form Transducer ×
7L5P
Model: 510(k) Number(s)
System
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | M | CWD | Color | Amplitude | Combined | Other (specify) | ||
| B | PWD | Doppler | Doppler | (specify) | ||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | Note 1.2 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | Note 1.2 | |
| Small organ(specify) ** | N | N | N | N | N | N | Note 1.2 | |
| Neonatal Cephalic | N | N | N | N | N | N | Note 1,2 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | N | N | N | N | N | N | Note 1,2 | |
| Conventional | ||||||||
| Musculo-skeletal Superficial | N | N | N | N | N | N | Note 1,2 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | N | N | N | N | N | N | Note 1.2 | |
| 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, Color+B+PW, Power+B+PW | ||||||||
| * 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: 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 Devices Evaluation and Safety agnostic Devi Office of In રાભર
11
Diagnostic Ultrasound Indications for Use Form Transducer ×
L14-6P
System Model: 510(k) Number(s)
. .
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | Note 1,2 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | Note 1,2 | |
| Small organ(specify)** | N | N | N | N | N | N | Note 1,2 | |
| Neonatal Cephalic | N | N | N | N | N | N | Note 1.2 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | N | N | N | N | N | N | Note 1,2 | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | Note 1.2 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | N | N | N | N | N | N | Note 1,2 | |
| 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, Color+B+PW, Power+B+PW | ||||||||
| * 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: 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)
Michael D'Okon
Chison Sign-Off)
Division of Radiological Devices
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K
12
Mindray Co.,LTD -Z6 Diagnostic Ultrasound System
Diagnostic Ultrasound Indications for Use Form Transducer
ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
CB10-4P
System Model: 510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| 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 |
| 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 | N | N | N | N | N | N | Note 1,2 |
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801:109)
(Division Sign-Off)
(Division of Radiological Devices Office of In Vitro Division of Hadlological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety 510K
13
Mindray Co.,LTD.-Z6 Diagnostic Ultrasound System
Diagnostic Ultrasound Indications for Use Form Transducer ×
. .
V10-4BP
| Model: | |
|---|---|
| 510(k) Number(s) |
System
| 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 |
| 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 |
| Trans-vaginal | N | N | N | N | N | N | N | Note 1, 2 |
| 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 | N | Note 1, 2 |
| 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, Color+B+PW, Power+B+PW | ||||||||
| * 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: 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)
Michael D. O'Hara
(Division Sign-Off)
(Division of Radiological Devices
Division of Radiological Devices
Vitro Diagnostic Device Evaluetion and Safety Office of In
14
Mindray Co.,LTD -Z6 Diagnostic Ultrasound System
Diagnostic Ultrasound Indications for Use Form Transducer
7LT4P
x
System Model: 510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | Note 1,2 | |
| Intraoperative (specify)* | N | N | N | N | N | N | Note 1,2 | |
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | Note 1,2 | |
| Small organ(specify)** | N | N | N | N | N | N | Note 1,2 | |
| Neonatal Cephalic | N | N | N | N | N | N | Note 1,2 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | N | N | N | N | N | N | Note 1,2 | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | Note 1,2 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | N | N | N | N | N | N | Note 1,2 | |
| 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, Color+B+PW, Power+B+PW | ||||||||
| * 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: 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)
પ
(Division Sign-Off)
Division of Radiological Devices
Pice Disconoctic Devices Evaluation Office of In Vitro Diagnostic Device Evaluation and Safety
15
Mindray Co.,LTD .- Z6 Diagnostic Ultrasound System
| Diagnostic Ultrasound Indications for Use Form | |||
|---|---|---|---|
| Transducer | × | ||
| 6LE7P |
Model: 510(k) Number(s)
System
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| 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 | |
| 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 | N | N | N | N | N | Note 1,2 | |
| 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+E | ||||||||
| * 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: 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) ·
Ar (Division Sign-Off)
(Division of Radiological Devices Division of Radiological Devices
Vitro Diagnostic Device Evaluation and Safety Office of In
16
Diagnostic Ultrasound Indications for Use Form . Transducer
.
2P2P
×
System Model:
510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1,2 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1,2 |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,2 |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1,2 |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,2 |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | ||||||||
| Other (specify)*** |
**Small organ-breast, thyroid, testes
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note8: 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)
Andrew D'Amico
(Division Sign-Off) Division of Radiological Devices Evaluation and Safety Diagnostic Devi Office of Ir
ice of In Vitro Diagnostic Device Evaluation and Safety
K122010
510K