(43 days)
K#091491, K#072164, K#071985, K#090276, K#060993, K#060542
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound technology and modes.
No
The system is explicitly described as a "diagnostic ultrasound system" and is used for imaging, not treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The DC-7 diagnostic ultrasound system is designed for M, B, pulsed doppler, continuous Doppler, color Doppler, power Doppler modes, and combined modes (i.e. B/M Mode)." Additionally, the "Device Description" section refers to it as "The DC-7 Diagnostic Ultrasound System."
No
The device description explicitly states it is a "software controlled, ultrasound diagnostic system" and mentions "an array of probes" and "optional biopsy needle guides that attach to the transducers," indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states the DC-7 is a "Diagnostic Ultrasound System." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve the analysis of specimens taken from the body.
- Intended Use/Indications for Use: The listed indications are for imaging various anatomical sites within the body (fetal, abdominal, cardiac, etc.). This is consistent with an in-vivo imaging device, not an in-vitro diagnostic device.
The information provided describes a standard diagnostic ultrasound machine used for imaging the inside of the body, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The DC-7 diagnostic ultrasound system is designed for M, B, pulsed doppler, continuous Doppler, color Doppler, power Doppler modes, and combined modes (i.e. B/M Mode). The system is indicated for fetal, abdominal, pediatric, small organ (breast, thyroid, and testes), cephalic (neonatal and adult), transvaginal, peripheral vascular, musculo-skeletal (conventional and superficial), and cardiac (neonatal and adult). The system includes optional biopsy needle guides that attach to the transducers.
Product codes
IYN, IYO, ITX
Device Description
The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. This system is a Track 3 device that employs an array of probes that include linear array probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 2.0 MHz to 12.0 MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
fetal, abdominal, pediatric, small organ (breast, thyroid, and testes), cephalic (neonatal and adult), transvaginal, peripheral vascular, musculo-skeletal (conventional and superficial), and cardiac (neonatal and adult)
Indicated Patient Age Range
pediatric, neonatal, adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The DC-7 Diagnostic Ultrasound System had been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA UD 3: 2004 Standards for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#091491, K#072164, K#071985, K#090276, K#060993, K#060542
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
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: _______________________________________________________________________________________________________________________________________________
OCT 1 5 2009
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 8611 9549 Fax: +86 755 2658 2680
Contact Person: Sheng Haobin 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 31, 2009
- Device Name: DC-7 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 Transduccr (90-ITX)
3. Marketed Device:
DC-7 Diagnostic Ultrasound System is substantially equivalent to the following devices: Mindray DC-3 (K#091491), Mindray DC-6 (K#072164), GE Vivid S6 (K#071985), Siemens X300 (K#090276), GE Logiq P5 (K#060993), GE Vivid 7 (K#060542).
1
4. Device Description:
The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. This system is a Track 3 device that employs an array of probes that include linear array probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 2.0 MHz to 12.0 MHz.
5. Intended Use:
.
The DC-7 diagnostic ultrasound system is designed for M, B, pulsed doppler, continuous Doppler, color Doppler, power Doppler modes, and combined modes (i.e. B/M Mode). The system is indicated for fetal, abdominal, pediatric, small organ (breast, thyroid, and testes), cephalic (neonatal and adult), transvaginal, peripheral vascular, musculo-skeletal (conventional and superficial), and cardiac (neonatal and adult). The system includes optional biopsy needle guides that attach to the transducers.
6. Safety Considerations:
The DC-7 Diagnostic Ultrasound System had been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA UD 3: 2004 Standards for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1.
Conclusion:
The conclusions drawn from testing of the DC-7 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices.
0032
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JAN - 4 2010
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298
Re: K092691
Trade/Device Name: DC-7 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: September 29, 2009 Received: September 30, 2009
Dear Mr. Mosenkis:
This letter corrects our substantially equivalent letter of October 15, 2009.
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 DC-7 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 3C5A, C5-2
V10-4, V10-4B
6C2
7L4A, 7L5, L12-4, L7-3, L11-4 | L14-6
2P2
4CD4 |
| --------------------------------------------------------------------- | ---------------------- |
|---|
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Mr. Paul Hardy at (301) 796-6542.
Sincerely yours,
logu M. Whig
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
4
System Model:
Transducer × DC-7
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 | Note1,2, 3, 4,7,8 |
| Abdominal | N | N | N | N | N | N | N | Note1, 2, 3, 4,5,7,8 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,5,7,8 |
| Small organ(specify)** | N | N | N | N | N | N | N | Note1, 2, 4,7,8 |
| Neonatal Cephalic | N | N | N | N | N | N | N | Note1, 2, 4,5,7,8 |
| Adult Cephalic | N | N | N | N | N | N | N | Note1, 2, 4,5,7,8 |
| Trans-rectal | N | N | N | N | N | N | N | Note 1,2,4,7,8 |
| Trans-vaginal | N | N | N | N | N | N | N | Note 1,2,4,7,8 |
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | N | N | N | N | N | N | N | Note 1,2,4,7,8 |
| Musculo-skeletal | ||||||||
| Superficial | N | N | N | N | N | N | N | Note 1,2,4,7,8 |
| Intravascular | ||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1,2,5,7,8 |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,2,5,7,8 |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | Note 1,2,4,7,8 |
| 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. | ||||||||
| 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: Contrast Imaging | ||||||||
| Note7: Color M | ||||||||
| Note8: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| System | Transducer | X | ||||||
| Model: | 3C5A, C5-2 | |||||||
| 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, 4,7,8 |
| Abdominal | N | N | N | N | N | N | N | Note 1, 2, 4,7,8 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,7,8 |
| 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 | N | Note 1, 2, 4,7,8 |
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | Note 1, 2, 4,7,8 |
| 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. | ||||||||
| 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: Contrast Imaging | ||||||||
| Note7: Color M | ||||||||
| Note8: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||
| System | Transducer | X | ||||||
| Model: | V10-4, V10-4B | |||||||
| 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 | Note 1, 2, 4,7,8 | |
| 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, 4,7,8 |
| Trans-vaginal | N | N | N | N | N | N | N | Note 1, 2, 4,7,8 |
| 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 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. | ||||||||
| **Small organ-breast, thyroid, testes, etc. | ||||||||
| 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: Contrast Imaging | ||||||||
| Note7: Color M | ||||||||
| Note8: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||
| System | Transducer | X | ||||||
| Model: | 6C2 | |||||||
| 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, 4,7,8 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | Note 1, 2, 4,7,8 | |
| Small organ(specify) ** | ||||||||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1, 2, 4,7,8 | |
| Adult Cephalic | N | N | N | N | N | N | Note 1, 2, 4,7,8 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | Note 1, 2, 4,7,8 | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | Note 1, 2, 4,7,8 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | N | N | N | Note 1, 2, 4,7,8 | |
| 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. | ||||||||
| 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 : Contrast Imaging | ||||||||
| Note7 : Color M | ||||||||
| Note8 : Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||
| Clinical Application | Mode of Operation | |||||||
| B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | Note 1,2, 4,7,8 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | Note 1,2, 4,7,8 | |
| Small organ(specify) ** | N | N | N | N | N | N | Note 1,2, 4,7,8 | |
| Neonatal Cephalic | N | N | N | N | N | N | Note 1,2, 4,7,8 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | Note 1,2, 4,7,8 | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | Note 1,2, 4,7,8 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | N | N | N | Note 1,2, 4,7,8 | |
| 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. | ||||||||
| 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: Contrast Imaging | ||||||||
| Note7: Color M | ||||||||
| Note8: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
5
Prescription USE (Per 21 CFR 801.109)
K092691
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
6
ರಿದ್ದಾರೆ. ಇದರ್
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
7
Prescription USE (Pcr 21 CFR 801.109)
K092691
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
Division of City of Cladiological Devices 510(k) Number -
8
| System | Transducer | X |
|---|---|---|
| Model: | 7L4A, 7L5, L12-4, L7-3, L11-4 | |
| 510(k) Number(s) |
c92691
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal and Division of the Property of Radiological Devices
Radiological Number Radionograppen
510 (k) Number
9
System
| Model: | L14-6 | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer | X | |||||||
| 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, 4,7 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | Note 1,2, 4,7 | |
| Small organ(specify)** | N | N | N | N | N | N | Note 1,2, 4,7 | |
| Neonatal Cephalic | N | N | N | N | N | N | Note 1,2, 4,7 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | Note 1,2, 4,7 | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | Note 1,2, 4,7 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | N | N | N | Note 1,2, 4,7 | |
| 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. | ||||||||
| 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: Contrast Imaging | ||||||||
| Note7: Color M | ||||||||
| Note8: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
Diagnostic Ultrasound Indications for Use Form Transducer
×
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
10
System
Modcl:
5 I 0(k) Number(s)
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PW | ||||||
| D | CWD | Color | ||||||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2,5,7,8 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2,5,7,8 |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2,5,7,8 |
| Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2,5,7,8 |
| 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, 2,5,7,8 |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2,5,7,8 |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify)*** |
Diagnostic Ultrasound Indications for Use Form Transducer
2P2
×
Prescription USE (Per 21 CFR 801.109)
:
(Division Sign-Off) Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
11
| System | Transducer | X | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Model: | 4CD4 | ||||||||
| 510(k) Number(s) | |||||||||
| Mode of Operation | |||||||||
| Clinical Application | B | M | PW | ||||||
| D | CWD | Color | |||||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | Note1,2, 3, 4,7 | ||
| Abdominal | N | N | N | N | N | N | Note1,2, 3, 4,7 | ||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | Note1, 2, 3, 4,7 | ||
| 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 | |||||||||
| 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. | |||||||||
| 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: Contrast Imaging | |||||||||
| Note7: Color M | |||||||||
| Note8: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal and Division ogical Devices 510(k) Number