(340 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound technology.
No
The device is described as a "diagnostic ultrasound imaging system" and its intended use is for "evaluation" of various body parts. There is no mention of therapeutic treatment or intervention.
Yes.
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or Doppler analysis of the human body," and the "Device Description" refers to it as a "diagnostic ultrasound system."
No
The device description clearly states it is a "mobile console" with a keyboard, display panel, and monitor, indicating it is a hardware system, not software only.
Based on the provided information, the LOGIQ 700 with 3D is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that it is a "general purpose ultrasound imaging system" used for "diagnostic ultrasound imaging or Doppler analysis of the human body". This involves imaging within the body, not testing samples outside the body.
- Device Description: The description details a physical console, transducers, keyboard, and monitor – components typical of an imaging system, not an IVD device that would handle biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes associated with in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is for direct imaging of the body.
N/A
Intended Use / Indications for Use
LOGIQ 700 with 3D is a general purpose ultrasound imaging system intended for use by, or under the direction of, a qualified physician in the evaluation of soft tissue and vascular disease of the head, neck chest, abdomen pelvis, male and female reproductive organs, limbs and pregnant uterus of the adult, pediatric or neonatal patient.
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Clinical Application: Fetal and other, Abdominal, Cardiac Adult, Cardic Pediatric, Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Peripheral vessel, Trans-rectal, Trans-vaginal.
Mode of Operation: A, B, M, PWD, Color Doppler, Power (Amplitude) Doppler. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.
Product codes (comma separated list FDA assigned to the subject device)
90 IYO
Device Description
The LOGIQ 700 diagnostic ultrasound system with 3D is the same in all other aspects as the currently marketed LOGIQ 700, consisting of a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability, and assorted transducers. The user interface is an adjustable height keyboard, small A/N display panel and a color video display monitor. Optional image storage or hard-copy devices are integrated into the design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic ultrasound imaging or Doppler analysis
Anatomical Site
Head, neck chest, abdomen pelvis, male and female reproductive organs, limbs, pregnant uterus, breast, testes, thyroid.
Indicated Patient Age Range
Adult, pediatric, or neonatal patient.
Intended User / Care Setting
Qualified physician
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 device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device 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.
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
Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular shape. The logo is black and white and has a vintage look.
GE LOGIQ 700 3D Premarket Notification - October 25, 1996
0571 - 3 1997
の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時
510(k) Summary of Safety and Effectiveness: GE LOGIQ 700 3D Cine
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
| Identification of Submitter: | GE Medical Systems
PO Box 414
Milwaukee, WI 53201 |
|------------------------------|---------------------------------------------------------------|
| Contact : | D. Duersteler, Safety and Regulatory Programs
414-647-4385 |
| Date Prepared: | October 25, 1996 |
Product Identification: GE LOGIQ 700 Diagnostic Ultrasound System with 3D Cine.
Marketed Devices: The GE LOGIQ 700 Diagnostic Ultrasound System with 3D is of a comparable tvpe and substantially equivalent to the GE Medical Systems LOGIQ 700 diagnostic ultrasound system, 510(k) Number K930768, currently in commercial distribution:
Device Description: The LOGIQ 700 diagnostic ultrasound system with 3D is the same in all other aspects as the currently marketed LOGIQ 700, consisting of a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability, and assorted transducers. The user interface is an adjustable height keyboard, small A/N display panel and a color video display monitor. Optional image storage or hard-copy devices are integrated into the design.
Indications for Use: LOGIQ 700 with 3D is a general purpose ultrasound imaging system intended for use by, or under the direction of, a qualified physician in the evaluation of soft tissue and vascular disease of the head, neck chest, abdomen pelvis, male and female reproductive organs, limbs and pregnant uterus of the adult, pediatric or neonatal patient.
Comparison with Predicate Device: The GE LOGIQ 700 with 3D is comparable in key safety and effectiveness features, uses the same design, construction, and materials, and has the same intended uses and operating modes as the predicate device.
Summary of Studies: The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with GMP standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE LOGIQ 700 with 3D Cine is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with human profiles incorporated into the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David Duersteler Safety/Regulatory Project Engineer GE Medical Systems PO Box 414 Milwaukee, WI 53201
OCT ﺯ
Re: K964617 Dated: August 25, 1997 Received: August 27, 1997 Regulatory Class: II 21 CFR 892.1550/Procode: 90 IYO
Dear Mr. Duersteler:
We have reviewed your section 510(k) 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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good --manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the LOGIQ 700 with 3D View, as described in your premarket notification:
Transducer Model Number
| 326s | 618E | 348C | LA39 |
|---|---|---|---|
| 547L | 618C | 227s | M3C |
| 739L | 548C | 546L | M12L |
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. David Duersteler
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Maureen Butler at (301) 594-1212.
Sincerely yours,
Chmil li. Segnon
for
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
510(k) Number (if known): K964617 Device Name: LOGIQ 700 326s Transducer
Fill out one form for each ultrasound system or transducer
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | ||||||||||
| Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal and other | X | X | X | X | X | X | X | |||
| Abdominal | X | X | X | X | X | X | X | |||
| Musculoskeletal | ||||||||||
| Intra-operative | ||||||||||
| Neurosurgical | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Specify) | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | X | X | X | X | X | X | X | |||
| Cardic Pediatric | X | X | X | X | X | X | X | |||
| Trans- | ||||||||||
| esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-urethral | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic |
Mode of Oneration
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.
(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)
・・・
Vernal h. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic
510(k) Number K160407
:
4
510(k) Number (if known): K964617 Device Name: LOGIQ 700 547L Transducer
Fill out one form for each ultrasound system or transducer
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | ||||||||||
| Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal and other | X | X | X | X | X | X | ||||
| Abdominal | ||||||||||
| Musculoskeletal | ||||||||||
| Intra-operative | ||||||||||
| Neurosurgical | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Specify) | X | X | X | X | X | X | ||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardic Pediatric | ||||||||||
| Trans- | ||||||||||
| esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-urethral | ||||||||||
| Peripheral vessel | X | X | X | X | X | X | ||||
| Laparoscopic |
Mode of Operation
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.
(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)
Kevint. Segerson
(Division Sign-Off) (Division of Reproductive, Abdominal, EN and Radiologi 510(k) Number
5
510(k) Number (if known): K964617
Device Name: LOGIQ 700 739L Transducer
Fill out one form for each ultrasound system or transducer
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|--------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal and other | | X | X | X | | X | X | | X | |
| Abdominal | | | | | | | | | | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | X | X | X | | X | X | | X | |
| Small Organ
(Specify) | | X | X | X | | X | X | | X | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-
esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | X | X | X | | X | X | | X | |
| Laparoscopic | | | | | | | | | | |
Mode of Operation
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.
(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)
����
L'hirond G. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
6
510(k) Number (if known): K964617 Device Name: LOGIQ 700 618E Transducer
Fill out one form for each ultrasound system or transducer
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | ||||||||||
| Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal and other | X | X | X | X | X | X | ||||
| Abdominal | ||||||||||
| Musculoskeletal | ||||||||||
| Intra-operative | ||||||||||
| Neurosurgical | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Specify) | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Trans- | ||||||||||
| esophageal | ||||||||||
| Trans-rectal | X | X | X | X | X | X | ||||
| Trans-vaginal | X | X | X | X | X | X | ||||
| Intra-luminal | ||||||||||
| Trans-urethral | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic |
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.
(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)
Daniel A. DiGeron
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devices 510(k) Number
Mode of Operation
7
510(k) Number (if known): K964617 Device Name: LOGIQ 700 618C Transducer
Fill out one form for each ultrasound system or transducer
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|--------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal and other | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | X | X | X | X | | X | X | | X | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | X | X | X | X | | X | X | | X | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans- | | | | | | | | | | |
| esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | X | X | X | X | | X | X | | X | |
| Laparoscopic | | | | | | | | | | |
Mode of Operation
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elnit A. Seppman
(Division Sign-C Division of Reproductive, Abdominal, EN and Radiological De 510(k) Number
8
510(k) Number (if known): K964617 Device Name: LOGIQ 700 548C Transducer
Fill out one form for each ultrasound system or transducer
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | ||||||||||
| Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal and other | X | X | X | X | X | X | X | |||
| Abdominal | X | X | X | X | X | X | X | |||
| Musculoskeletal | ||||||||||
| Intra-operative | ||||||||||
| Neurosurgical | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Specify) | X | X | X | X | X | X | X | |||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardic Pediatric | ||||||||||
| Trans- | ||||||||||
| esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-urethral | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic |
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David M. Seymon
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number
9
510(k) Number (if known): K964617 Device Name: LOGIQ 700 348C Transducer
Fill out one form for each uitrasound system or transducer
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Opthalmic | ||||||||||
| Fetal and other | X | X | X | X | X | X | X | |||
| Abdominal | X | X | X | X | X | X | X | |||
| Musculoskeletal | ||||||||||
| Intra-operative | ||||||||||
| Neurosurgical | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | X | X | X | X | X | X | X | |||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardic Pediatric | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-urethral | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic |
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.
(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)
David A. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Dev
510(k) Number K960461-7
10
510(k) Number (if known): K964617 Device Name: LOGIQ 700 227s Transducer
Fill out one form for each ultrasound system or transducer
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | ||||||||||
| Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal and other | X | X | X | X | X | X | ||||
| Abdominal | X | X | X | X | X | X | ||||
| Musculoskeletal | ||||||||||
| Intra-operative | ||||||||||
| Neurosurgical | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Specify) | X | X | X | X | X | X | ||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardic Pediatric | ||||||||||
| Trans- | ||||||||||
| esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-urethral | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic |
Mode of Oneration
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David L. Severson
(Division S Division of eproductive, Abdominal, B and Rad 510(k) Number
11
510(k) Number (if known): K964617 Device Name: LOGIQ 700 546L Transducer
Fill out one form for each ultrasound system or transducer
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|--------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal and other | | X | X | X | | X | X | | X | |
| Abdominal | | | | | | | | | | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | X | X | X | | X | X | | X | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardic Pediatric | | | | | | | | | | |
| Trans- | | | | | | | | | | |
| esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | X | X | X | | X | X | | X | |
| Laparoscopic | | | | | | | | | | |
Mode of Operation
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.
(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)
David G. Segerson
(Division Division of Reproductive, Abdominal, ENT and Radiological Dev
510(k) Number R4674011
12
510(k) Number (if known): K964617
Device Name: LOGIQ 700 LA39 Transducer
Fill out one form for each ultrasound system or transducer
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | ||||||||||
| Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal and other | X | X | X | X | X | X | ||||
| Abdominal | ||||||||||
| Musculoskeletal | ||||||||||
| Intra-operative | ||||||||||
| Neurosurgical | ||||||||||
| Pediatric | X | X | X | X | X | X | ||||
| Small Organ | ||||||||||
| (Specify) | X | X | X | X | X | X | ||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Trans- | ||||||||||
| esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-urethral | ||||||||||
| Peripheral vessel | X | X | X | X | X | X | ||||
| Laparoscopic |
Mode of Oneration
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seymour
Division of Reproductive, Abdominal, EN and Radiological Dev
510(k) Number K964617
13
510(k) Number (if known): K964617 Device Name: LOGIQ 700 M3C Transducer
Fill out one form for each ultrasound system or transducer
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | ||||||||||
| Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal and other | X | X | X | X | X | X | ||||
| Abdominal | X | X | X | X | X | X | X | |||
| Musculoskeletal | ||||||||||
| Intra-operative | ||||||||||
| Neurosurgical | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Specify) | X | X | X | X | X | X | X | |||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardic Pediatric | ||||||||||
| Trans- | ||||||||||
| esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-urethral | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic |
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.
(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)
Thuriel C. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number
14
510(k) Number (if known): K964617 Device Name: LOGIQ 700 M12L Transducer
Fill out one form for each ultrasound system or transducer
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | |||||||||||
| Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Power | ||||||||||
| (Amplitude) | |||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal and other | X | X | X | X | X | X | |||||
| Abdominal | |||||||||||
| Musculoskeletal | |||||||||||
| Intra-operative | |||||||||||
| Neurosurgical | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (Specify) | X | X | X | X | X | X | |||||
| Neonatal | |||||||||||
| Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac Adult | |||||||||||
| Cardic Pediatric | |||||||||||
| Trans- | |||||||||||
| esophageal | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Intra-luminal | |||||||||||
| Trans-urethral | |||||||||||
| Peripheral vessel | X | X | X | X | X | X | |||||
| Laparoscopic |
Mode of Operation
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elnord C. Ferguson
(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological Devig 510(k) Number