(580 days)
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and urological, Musculoskeletal, Abdominal. Pediatric. Small Organ including breast, testes and thyroid, Neonatal Cephalic, Cardiac Adult, Cardic Pediatric, Trans-rectal, Trans-vaginal, and Peripheral vessel.
The modified GE LOGIQ 700 diagnostic ultrasound system consists 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
The provided document, a 510(k) summary for the modified GE LOGIQ 700 Diagnostic Ultrasound System, does not describe quantitative acceptance criteria or a specific study proving the device meets performance claims. Instead, it focuses on demonstrating substantial equivalence to a predicate device already on the market.
Therefore, the following information, relating to performance studies with specific quantitative acceptance criteria, cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with/without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
Description of the Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria:
The acceptance criteria for the modified GE LOGIQ 700 Diagnostic Ultrasound System are implicitly based on demonstrating that it is substantially equivalent to a predicate device, the GE Medical Systems LOGIQ 700 diagnostic ultrasound system (510(k) Number K930768).
The study performed to demonstrate this substantial equivalence involved:
- Comparison of safety and effectiveness features: The modified device was deemed comparable to the predicate regarding "key safety and effectiveness features."
- Design, construction, and materials: The new device uses "similar design, construction, and materials."
- Intended uses and operating modes: The modified device has "the same intended uses and operating modes."
- Compliance with safety standards: The device underwent evaluation for "acoustic output, biocompatibility, and thermal, electrical and mechanical safety" and was found to conform with applicable medical device safety standards.
- Compliance with GMP standards: The manufacturer's design and development process conforms with "GMP standards."
The core of the "study" is a comparison to the predicate device and adherence to general medical device safety standards and manufacturing practices, rather than a specific clinical performance study with predefined quantitative endpoints. The FDA's letter further reinforces this by stating, "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."
The FDA's clearance (K960527) is granted on the condition that the manufacturer submits a post-clearance special report containing "acoustic output measurements based on production line devices," as requested in Appendix G of the 1993 "Revised 510(k) Diagnostic Ultrasound Guidance." This indicates that ongoing acoustic output performance would be an acceptance criterion to maintain clearance.
{0}------------------------------------------------
O=i - O - 33
K. Wood
510(k) Summary of Safety and Effectiveness
Modified GE LOGIQ 700 Premarket Notification K960527
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 SystemsPO Box 414Milwaukee, WI 53201 |
|---|---|
| Contact : | D. Duersteler, Safety/Regulatory Projebt Engineer414-548-4839 |
| Date Prepared: | January 30, 1996; Revised July 1, 1997 |
Product Identification: Modified GE LOGIQ 700 Diagnostic Ultrasound System
Marketed Devices: The modified GE LOGIQ 700 is of a comparable type and substantially equivalent to the GE Medical Systems LOGIQ 700 diagnostic ultrasound system, 510(k) Number K930768, currently in commercial distribution:
Device Description: The modified GE LOGIQ 700 diagnostic ultrasound system consists 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: The modified GE LOGIQ 700 is a general purpose ultrasound imaging system intended for use by or under the direction of a qualified physician for Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and urological, Musculoskeletal, Abdominal. Pediatric. Small Organ including breast, testes and thyroid, Neonatal Cephalic, Cardiac Adult, Cardic Pediatric, Trans-rectal, Trans-vaginal, and Peripheral vessel.
Comparison with Predicate Device: The modified GE LOGIQ 700 is comparable in key safety and effectiveness features, uses similar 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 quidelines, 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 modified GE LOGIQ 700 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
{1}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
D. Duersteler Safety/Regulatory Project Engineer General Electric Medical Systems P.O. Box 414 Milwaukee, WI 53201
Re: K960527 GE LOGIO 700 Diagnostic Ultrasound System Dated: July 1, 1997 Received: July 2, 1997 Regulatory class: II 21 CFR 892.1550/Procode: 90 IYN
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 modified GE LOGIQ 700 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
618E 348C LA39 326s 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 Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through
Image /page/1/Picture/11 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion. The text is in all caps and is written in a simple, sans-serif font.
SEP - 8 1997
{2}------------------------------------------------
Page 2 - D. Duersteler
periodic GMP inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's February 17, 1993 "Revised 510(k) Diagnostic Ultrasound Guidance for 1993." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
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
{3}------------------------------------------------
Page 3 - D Duesteler
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 Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Elwind h. Segerson
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
Enclosures
{4}------------------------------------------------
510(k) Number (if known): K960527 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:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | 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) | ||||||||||
| NeonatalCephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | X | X | X | X | X | X | ||||
| Cardiac Pediatric | X | X | X | X | X | X | ||||
| Trans-esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-urethral | ||||||||||
| Peripheral vessel | ||||||||||
| 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)
David In. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological
510(k) Number K960527
{5}------------------------------------------------
510(k) Number (if known): K960527 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Opthalmic | ||||||||||
| Fetal and other | X | X | X | X | X | X | ||||
| Abdominal | ||||||||||
| Musculoskeletal | X | X | X | X | X | X | ||||
| 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 A. Seysson
(Divis Reproductive, Abdominal, EN Division and Rad 210
{6}------------------------------------------------
510(k) Number (if known): K960527 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:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Opthalmic | ||||||||||
| Fetal and other | X | X | X | X | X | X | X | |||
| Abdominal | ||||||||||
| Musculoskeletal | X | X | X | X | X | X | X | |||
| Intra-operative | ||||||||||
| Neurosurgical | ||||||||||
| Pediatric | X | X | X | X | X | X | X | |||
| Small Organ(Specify) | X | 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 | X | |||
| 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 Ch. Seymour
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiolog 510(k)
{7}------------------------------------------------
Page 1 of 1
510(k) Number (if known): K964886 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | 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 |
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)
David A. Segmon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiolog 510(k) Numb
{8}------------------------------------------------
Page 1 of 1
510(k) Number (if known): K964886 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:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Opthalmic | ||||||||||
| Fetal and other | ||||||||||
| Abdominal | ||||||||||
| Musculoskeletal | ||||||||||
| Intra-operative | ||||||||||
| Neurosurgical | ||||||||||
| Pediatric | X | X | X | X | X | X | ||||
| Small Organ(Specify) | ||||||||||
| Neonatal | X | X | X | X | X | X | ||||
| 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)
David A. Severson
(Division Reproductive, Abdominal, El Division and Rad 510(k) Number
{9}------------------------------------------------
510(k) Number (if known): K960527 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | 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 |
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 Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
{10}------------------------------------------------
510(k) Number (if known): K960527 Device Name: LOGIQ 700 348C 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:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | 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 Operation
Other Indications or Modes: Small organ includes breast, 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. Seymon
Division on- Off f Reproductive, Abdominal, EN Division and Radiological 510(k) Number
{11}------------------------------------------------
510(k) Number (if known): K960527 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:
| ClinicalApplication | A | B | M | PWD | CWD | Mode of Operation | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | 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 |
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. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Numbe
{12}------------------------------------------------
510(k) Number (if known): K960527 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:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Opthalmic | ||||||||||
| Fetal and other | X | X | X | X | X | X | ||||
| Abdominal | ||||||||||
| Musculoskeletal | X | X | X | X | X | X | ||||
| 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)
David b. Seymann
(Division Sign-Off) Division Reproductive, Abdominal, EN and F 510(k)
{13}------------------------------------------------
510(k) Number (if known): K964886 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 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Opthalmic | |||||||||||
| Fetal and other | X | X | X | X | X | X | |||||
| Abdominal | |||||||||||
| Musculoskeletal | X | X | X | X | X | X | |||||
| 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 |
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. Heyman
(Divisio') Reprenuetive, Abdominal, E Division and Radi
510(k) Number K960627
{14}------------------------------------------------
510(k) Number (if known): K960527 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | 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 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)
David C. Seymann
(Division Six a- Off) Repreductive, Abdominal, E Division of and Radiolo 510(k) Nu
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510(k) Number (if known): K960527 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Opthalmic | ||||||||||
| Fetal and other | X | X | X | X | X | X | ||||
| Abdominal | ||||||||||
| Musculoskeletal | X | X | X | X | X | X | X | |||
| 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 |
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)
Howard W. Diamond
(Division Si Dif) & Representive. Abdominal. Division and Radiological i 510(k) Number
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.