(51 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
No
The device is described as an "ultrasonic diagnostic imaging system" and its function is to "acquire and display ultrasound data," indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the system is a "Digital Ultrasonic Diagnostic Imaging System" and "ultrasonic diagnostic systems." It is used for various exams to acquire and display ultrasound data.
No
The device description explicitly states it is a "Digital Ultrasonic Diagnostic Imaging System" that employs "an array of transducers," which are hardware components essential for acquiring ultrasound data. While it is software-controlled, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an "Ultrasonic Diagnostic Imaging System" used for various anatomical exams on different patient populations. This is a description of an imaging device used in vivo (on a living patient) to visualize internal structures.
- Device Description: The description confirms it's an "ultrasonic diagnostic system" that acquires and displays ultrasound data. This aligns with in vivo imaging.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests in vitro (outside the body). IVDs are designed to examine these types of samples to provide diagnostic information.
Therefore, the DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System is applicable for adults. pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), pediatric cardiac, adult cardiac(only for DP-7), peripheral vessel and urology exams.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System are general purpose, mobile, software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, or their combined mode B+M Mode. The systems are Track 3 device that employs an array of transducers including linear array, convex array and phase array with a frequency range of approximately 2.0 MHz to 14.0 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, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (conventional, superficial), Cardiac (pediatric, adult), 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests: DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging Systems have 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K090912, K111435, K102991, K103677, K103583
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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: K113639
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 5615 Fax: +86 755 2658 2680
Contact Person:
Tan Chuanbin Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
November 8th, 2011 Date Prepared:
2. Device Name:
DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic Imaging System
Classification
Regulatory Class: II 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)
3. Device Description:
The DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System are general purpose, mobile, software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, or their combined mode B+M Mode. The systems are Track 3 device that employs an array of transducers including linear array,
B-1
1
convex array and phase array with a frequency range of approximately 2.0 MHz to 14.0 MHz.
4. Intended Use:
The DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System is applicable for adults. pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), pediatric cardiac, adult cardiac(only for DP-7), peripheral vessel and urology exams.
5. Comparison with Predicate Device:
DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System is comparable with and substantially equivalent to the Mindray DP-6900 Digital Ultrasonic Diagnostic Imaging System (K090912), DP-50(only for DP-5) Digital Ultrasonic Diagnostic Imaging System ( K111435), M5 Diagnostic Ultrasound System(K102991) and M7 Diagnostic Ultrasound System(K 103677), DC-7(only for DP-7) Diagnostic Ultrasound System (K103583). They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate device.
6. Non-clinical Tests:
DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging Systems have 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: ISO 14971, UD 2, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, UL 60601-1 and IEC 62304.
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 devices conform to applicable medical device safety standards. Therefore, the DP-7 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the caduceus symbol.
FEB 1 0 2012
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Shenzhen Mindray Bio-Medical Electronics Co., Ltd % Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Inc 55 Northern Blvd, Suite 200 GREAT NECK NY 11021
Re: K113632
Trade/Device Name: DP-5, DP-7 Digital Ultrasonic Diagnostic Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: January 9, 2012 Received: January 10, 2012
Dear Ms. Goldstein-Falk:
This letter corrects our substantially equivalent letter of January 25, 2012.
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 DUS 6000 Digital Ultrasonic Imaging System, as described in your premarket notification:
Transducer Model Number
| Probes for DP-5 | Probes for DP-7 |
|---|---|
| 35C50EA | 3C5P |
| 65C15EA | 6C2P |
3
| 65EC10EA | 6CV1P |
|---|---|
| 75L38EA | 7L4P |
| 75L53EA | 7L5P |
| 10L24EA | L14-6P |
| 65EB10EA | CB10-4P |
| 2P2P |
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/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 Jeffrey Ballyns, Ph.D. at (301) 796-6105.
Sincerely Yours,
Mary S Patel
Mary S. Pastel, Sc.D. 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: DP-5, DP-7 Digital Ultrasonic Diagnostic Imaging System
Indications for Use:
The DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic,, trans-rectal, trans-vaginal, musculo-skeletal, pediatric cardiac, adult cardiac(only for DP-7), peripheral vessel and urology exams.
AND/OR Over - The - Counter Use Prescription Use______________________________________________________________________________________________________________________________________________________________ (21 CFR Part 807 Subpart C) (21 CFR Part 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Postle
(Division Bign-Ort
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113 632
5
System Model:
Transducer DP-5
×
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 | Note 1,2 | ||||
| Abdominal | N | N | N | Note 1,2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | Note 1, 2 | ||||
| Small organ(specify)** | N | N | N | Note 1,2 | ||||
| Neonatal Cephalic | N | N | N | Note 1, 2 | ||||
| Adult Cephalic | N | N | N | Note 1, 2 | ||||
| Trans-rectal | N | N | N | Note 1, 2 | ||||
| Trans-vaginal | N | N | N | Note 1, 2 | ||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | N | N | N | Note 1,2 | ||||
| Musculo-skeletal | ||||||||
| Superficial | N | N | N | Note 1,2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | N | N | N | Note 1,2 | ||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | N | N | N | Note1, 2 | ||||
| Other (specify) *** | N | N | N | Note1, 2 |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M.
*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)
Mary S Patel
sion Sign-Off Division of Radiological Devices ic Device Evaluation and Safety Office of In
510K. K113632
6
35C50EA
×
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 | P | P | P | Note 1, 2 | ||||
| Abdominal | P | P | P | Note 1, 2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 1, 2 | ||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | P | P | P | Note 1, 2 | ||||
| Musculo-skeletal | ||||||||
| Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | P | P | P | Note 1, 2 | ||||
| Other (specify)*** |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M.
*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)
Mary S. Pastil
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K113632
510K
7
65C15EA
x
System Model:
510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | |||||
| D | CW | |||||||
| D | Color | |||||||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other | |||||||
| (specify) | ||||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | Note 1, 2 | |||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note 1, 2 | |||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | P | P | P | P | Note 1, 2 | |||
| Adult Cephalic | P | P | P | P | Note 1, 2 | |||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | ||||||||
| Musculo-skeletal | ||||||||
| Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | P | P | P | P | Note 1, 2 | |||
| 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.
- 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)
Mary S Patel
(Diffision Sign-Off) Division of Radiological Devices ice Evaluation and Safety
Office of In Vitro Diagnostic Device Evaluation and Sa
K113632
510K
8
×
System Model: 510(k) Number(s)
65EC10EA
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other | |||||||
| (specify) | ||||||||
| Ophthalmic | ||||||||
| Fetal | P | P | P | Note 1, 2 | ||||
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | Note 1, 2 | ||||
| Trans-vaginal | P | P | P | 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) *** | P | P | P | Note 1, 2 |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M.
*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)
Mary S. Postle
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
0033
9
75L38EA
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 | P | P | P | Note 1,2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 1,2 | ||||
| Small organ(specify)** | P | P | P | Note 1,2 | ||||
| Neonatal Cephalic | P | P | P | Note 1,2 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | P | P | P | Note 1,2 | ||||
| Musculo-skeletal | ||||||||
| Superficial | P | P | P | Note 1,2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | P | P | P | Note 1,2 | ||||
| Other (specify)*** |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M.
- 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)
Mary S. Pastel
510K
Division Sign-Off, Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sarel
10
×
System Model: 510(k) Number(s)
75L53EA
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other | |||||||
| (specify) | ||||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | Note 1,2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 1,2 | ||||
| Small organ(specify)** | P | P | P | Note 1,2 | ||||
| Neonatal Cephalic | P | P | P | Note 1,2 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | P | P | P | Note 1,2 | ||||
| Musculo-skeletal | ||||||||
| Superficial | P | P | P | Note 1,2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | P | P | P | Note 1,2 | ||||
| Other (specify)*** |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M.
*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)
Mary S. Pastel
Division Sign-Off
510K
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Satery
K 113632
11
10L24EA
×
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 | P | P | P | Note 1,2 | |||||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | Note 1,2 | |||||
| Small organ(specify)** | P | P | P | Note 1,2 | |||||
| Neonatal Cephalic | P | P | P | Note 1,2 | |||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| Conventional | P | P | P | Note 1,2 | |||||
| Musculo-skeletal | |||||||||
| Superficial | P | P | P | Note 1,2 | |||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral Vessel | P | P | P | Note 1,2 | |||||
| Other (specify)*** |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M.
*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 1: Tissue Harmonic Imaging. The feature does not use contrast age
Note 2: Biopsy Guidance
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)
Mary Sloss
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K13632
510K
—
12
×
System Model: 510(k) Number(s)
Transducer 65EB10EA
| 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 | P | P | P | 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)*** | P | P | P | Note 1, 2 |
N=new indication; P=previously cleared by FDA; E=added under Appendix E Additional comments Combined modes: B+M.
| Additional comments | Combined modes: B+M. |
|---|---|
| *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. | |
| Note2: 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)
Mary S. Pastel
510K
Division Sign-Off) Division of Radiological Devices gnostic Device Evaluation and Safety Office of In Vitro Dia
13
System Model:
Transducer DP-7
x
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 | Note 1,2 | ||||
| Abdominal | N | N | N | Note 1,2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | Note 1, 2 | ||||
| Small organ(specify)** | N | N | N | Note 1,2 | ||||
| Neonatal Cephalic | N | N | N | Note 1, 2 | ||||
| Adult Cephalic | N | N | N | Note1, 2 | ||||
| Trans-rectal | N | N | N | Note 1, 2 | ||||
| Trans-vaginal | N | N | N | Note 1, 2 | ||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | N | N | N | Note 1,2 | ||||
| Musculo-skeletal | ||||||||
| Superficial | N | N | N | Note 1,2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | N | N | N | Note 1,2 | ||||
| Cardiac Pediatric | N | N | N | Note 1,2 | ||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | N | N | N | Note1, 2 | ||||
| Other (specify)*** | 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.
| Additional comments: Combined model: B-M. |
|---|
| *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)
Mary Stott
.
(Diysion Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sefety
510K K113632
14
x
Transducer
3C5P
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 | P | P | P | Note 1, 2 | ||||
| Abdominal | P | P | P | Note 1, 2 | ||||
| Intraoperative | ||||||||
| (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 1, 2 | ||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | P | P | P | Note 1, 2 | ||||
| Musculo-skeletal | ||||||||
| Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | P | P | P | Note 1, 2 | ||||
| Other (specify)*** |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M.
*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)
Mace Slatl
(Division Sign-Off)
Division of Radiological Devic Office of in Vitro Diagnostic Device Evaluation and Safety
Office of In Vitro Diagnostic Device Evaluation and
510K. K113632
15
6C2P
×
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 | P | P | P | Note 1, 2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 1, 2 | ||||
| Small organ(specify)** | P | P | ||||||
| Neonatal Cephalic | P | P | P | Note 1, 2 | ||||
| Adult Cephalic | P | P | P | 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.
*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)
Mary S. Pastel
Division of Hallis Office of In Vitro Dit કાબર
16
6CV IP
×
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 | P | P | P | P | Note 1, 2 | |||
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | Note 1, 2 | |||
| Trans-vaginal | P | P | P | P | 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)*** | P | P | P | P | Note 1, 2 |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M.
*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)
Mary S. Pastel
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K113632
17
7L4P
×
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 | P | P | P | Note 1,2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 1,2 | ||||
| Small organ(specify)** | P | P | P | Note 1,2 | ||||
| Neonatal Cephalic | P | P | P | Note 1,2 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | P | P | P | Note 1,2 | ||||
| Musculo-skeletal | ||||||||
| Superficial | P | P | P | Note 1,2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | P | P | P | Note 1,2 | ||||
| Other (specify) *** |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M.
*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)
Mary Sostle
(Decision Sign Off)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K113632
18
7L5P
×
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 | P | P | P | Note 1,2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 1,2 | ||||
| Small organ(specify)** | P | P | P | Note 1,2 | ||||
| Neonatal Cephalic | P | P | P | Note 1,2 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | P | P | P | Note 1,2 | ||||
| Musculo-skeletal | ||||||||
| Superficial | P | P | P | Note 1,2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | P | P | P | Note 1,2 | ||||
| Other (specify)*** |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M. *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)
Mary S. Porter
Bon Sign-Off Division of Radiotogical Devices ice Evaluation and Safety
Office of In Vitro Diagnostic Device Evaluation and Safety
K113632
510K
19
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 | P | P | P | Note 1,2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 1,2 | ||||
| Small organ(specify)** | P | P | P | Note 1,2 | ||||
| Neonatal Cephalic | P | P | P | Note 1,2 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | P | P | P | Note 1,2 | ||||
| Musculo-skeletal | ||||||||
| Superficial | P | P | P | Note 1,2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vessel | P | P | P | Note 1,2 | ||||
| Other (specify)*** |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M.
*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)
Mary S. Patel
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
610K
20
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 | P | P | P | 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)*** | P | P | P | Note 1,2 |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M.
*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)
Maru Slotel
Asian Clarket Divisio of Bactellantial Devices & Fysluation and Safety Office of In દાભર
21
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 | P | P | P | Note 1,2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 1,2 | ||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | P | P | P | Note 1,2 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| Conventional | ||||||||
| Musculo-skeletal | ||||||||
| Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | P | P | P | Note 1,2 | ||||
| Cardiac Pediatric | P | P | P | Note 1,2 | ||||
| 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.
- 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. 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)
Mare Patel
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
5113632
510K