(340 days)
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: Fetal and other (includes urological), Abdominal, Cardiac Adult, Cardiac Pediatric, Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Peripheral vessel, Trans-rectal, Trans-vaginal. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.
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.
The provided text is a 510(k) summary for the GE LOGIQ 700 3D Cine diagnostic ultrasound system, submitted in 1996. This document evaluates the device for substantial equivalence to a predicate device, focusing on safety and effectiveness.
Here's an analysis of the requested information based only on the provided text, recognizing that some modern AI/ML device study criteria may not apply to a 1996 submission for an ultrasound system.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria or specific performance metrics in the way a modern AI/ML device submission would. Instead, the acceptance criteria are implicitly tied to demonstrating "substantial equivalence" to a predicate device. The performance is reported in a qualitative manner, confirming adherence to safety standards.
| Acceptance Criteria (Stated/Implied) | Reported Device Performance |
|---|---|
| Safety: Conformity with applicable medical device safety standards. | "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." |
| Effectiveness: Comparable key features, design, construction, materials, intended uses, and operating modes to the 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." |
| GMP Compliance: Conformance with Good Manufacturing Practices. | "The design and development process of the manufacturer conforms with GMP standards." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information regarding a specific "test set" in the context of an AI/ML algorithm. The evaluation described refers to acoustic output, biocompatibility, and thermal, electrical, and mechanical safety, which typically involve testing of the physical device components rather than a dataset of clinical cases. Therefore, there is no mention of sample size or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or not provided in the document. The submission is for a diagnostic ultrasound system and its transducers, not an AI/ML algorithm that requires expert-annotated ground truth for a test set of clinical images. The "ground truth" in this context would likely be physical measurements, engineering specifications, and established medical device safety limits.
4. Adjudication Method for the Test Set
This information is not applicable or not provided in the document. As there is no described test set requiring human interpretation for ground truth, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance
This information is not applicable or not provided in the document. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool. Therefore, a MRMC comparative effectiveness study comparing human readers with and without AI assistance was not performed or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable or not provided in the document. The device is a diagnostic ultrasound system, which inherently involves human operation and interpretation. It is not a standalone AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for this type of medical device submission (a diagnostic ultrasound system in 1996) centers around:
- Engineering Specifications and Safety Standards: The device's acoustic output, electrical safety, thermal safety, mechanical safety, and biocompatibility are measured against established industry and regulatory standards.
- Predicate Device Comparison: The "ground truth" for demonstrating effectiveness is the substantial equivalence to a legally marketed predicate device (GE Medical Systems LOGIQ 700, K930768) with a known history of safe and effective performance. This implies that the predicate device's established performance serves as the benchmark.
8. The Sample Size for the Training Set
This information is not applicable or not provided in the document. The GE LOGIQ 700 is a hardware and software system for image acquisition and display, not an AI/ML algorithm that is "trained" on a dataset in the modern sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided in the document, as there is no "training set" for an AI/ML algorithm associated with this device submission.
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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 SystemsPO Box 414Milwaukee, WI 53201 |
|---|---|
| Contact : | D. Duersteler, Safety and Regulatory Programs414-647-4385 |
| 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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:
| 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 | X | X | X | X | X | X | ||||
| Small Organ(Specify) | X | X | X | X | X | X | ||||
| NeonatalCephalic | ||||||||||
| 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
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:
| 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 | X | |||
| Small Organ(Specify) | ||||||||||
| NeonatalCephalic | 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 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:
| 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) | 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 | X | |||
| Musculoskeletal | ||||||||||
| Intra-operative | ||||||||||
| Neurosurgical | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | X | X | X | X | X | X | X | |||
| NeonatalCephalic | ||||||||||
| 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 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | X | X | X | X | X | X | |||||
| NeonatalCephalic | |||||||||||
| 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
§ 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.