(235 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware and standard ultrasound functionalities.
No
The 'Intended Use' clearly states the device is for "Diagnostic ultrasound imaging or Doppler analysis," indicating its purpose is to diagnose conditions rather than treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or Doppler analysis of the human body".
No
The device description explicitly states it consists of a mobile console, keyboard, display panel, monitor, and transducers, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or Doppler analysis of the human body". This describes an in-vivo diagnostic procedure, where the device interacts directly with the patient's body to obtain images and data.
- Device Description: The description details a mobile console, transducers, keyboard, display, and image storage. These are components of an ultrasound system used for imaging the inside of the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The provided information does not mention the analysis of any such specimens.
Therefore, this device is a diagnostic imaging device used on the human body, not an in-vitro diagnostic device used with specimens from the human body.
N/A
Intended Use / Indications for Use
The GE LOGIQ 700 including intra-operative and neurosurgical uses 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, Abdominal, Intra-operative of abdominal organs, Neurosurgical, Pediatric, Small Organ including breast, testes, thyroid, Neonatal Cephalic, Cardiac Adult, Cardic Pediatric, Trans-rectal, Transvaginal, and Peripheral vessel.
Product codes
90 IYN, 90 ITX
Device Description
The LOGIQ 700 including intra-operative and neurosurgical uses 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
ultrasound imaging or Doppler analysis
Anatomical Site
Fetal, Abdominal, Intra-operative of abdominal organs, Neurosurgical, Pediatric, Small Organ including breast, testes, thyroid, Neonatal Cephalic, Cardiac Adult, Cardic Pediatric, Trans-rectal, Transvaginal, and Peripheral vessel.
Indicated Patient Age Range
Not Found
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
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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 1997
D. Duersteler. ...... . ... . ... . .. Technology Product Assurance GE Medical Systems General Electric Company P.O. Box 414 Milwaukee, WI 53201
Re: K964886
GE LOGIQ 700 Diagnostic Ultrasound System Dated: June 18, 1997 Received: June 19, 1997 Regulatory class: II 21 CFR 892.1550/Procode: 90 IYN 21 CFR 892.1570/Procode: 90 ITX
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 GE LOGIQ 700 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 618C | 739I |
|---|---|
| LA39 | 739L |
| 739T |
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Page 2 - D. Duersteler
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 QS 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, 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.
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.
2
Page 3 - D. Duersteler
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 Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
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
3
Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular border. Three stylized swirls are positioned around the circle's perimeter, adding a dynamic element to the design.
JUL 2 9 1997
GE Medical Svstems
510(k) Summary of Safety and Effectiveness: GE LOGIQ 700
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/Regulatory Project Engineer
414-647-4385 |
| Date Prepared: | June 18, 1997 |
Product Identification: GE LOGIQ 700 diagnostic ultrasound system including intra-operative and neurosurgical uses.
Marketed Devices: The LOGIQ 700 with intra-operative and neurosurgical uses 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 LOGIQ 700 including intra-operative and neurosurgical uses 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: The GE LOGIQ 700 including intra-operative and neurosurgical uses 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, Abdominal, Intra-operative of abdominal organs, Neurosurgical, Pediatric, Small Organ including breast, testes, thyroid, Neonatal Cephalic, Cardiac Adult, Cardic Pediatric, Trans-rectal, Transvaginal, and Peripheral vessel.
Comparison with Predicate Device: The LOGIQ 700 including intra-operative and neurosurgical uses is comparable in key safety and effectiveness features, uses the same design, construction, and materials, and has the same operating modes as the predicate device. The intended uses are the same except for the addition of intra-operative use.
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.
4
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 LOGIQ 700 including intra-operative uses is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
5
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:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|--------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal and Other | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative | | X | X | X | | X | X | | X | |
| Neurosurgical | | X | X | X | | X | X | | X | |
| Pediatric | | X | X | X | | X | X | | X | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | | 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 | |
| Laparoscopic | | | | | | | | | | |
Mode of Operation
Other Indications or Modes: Small organ includes breast, testes, thyroid. Intra-operative includes abdominal organs. 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)
R.D. Robinson LLY
on Sion -Off Division of Reproductive, Abdominal, E and Radiological Devic 510(k) Number