(286 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
No
The document describes the device as a general purpose ultrasound imaging system intended for evaluation of soft tissue and vascular disease, which is a diagnostic purpose, not therapeutic.
Yes
The "Device Description" explicitly states, "The LOGIQ 500 diagnostic ultrasound system..."
No
The device description explicitly states it consists of a "mobile console and assorted transducers," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- LOGIQ 500 Function: The LOGIQ 500 is an ultrasound imaging system. It uses sound waves to create images of internal structures within the body. It does not analyze specimens taken from the body.
The provided information clearly describes a diagnostic imaging device used for visualizing internal anatomy, which is distinct from the function of an IVD.
N/A
Intended Use / Indications for Use
LOGIQ 500 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. Specific intended uses include Abdominal, Peripheral Vascular, OB/Gyn, Small Parts, Musculoskeletal, Urology, Neonatal, Cardiac, Fetal Doppler, Biopsy, Transrectal/transvaginal, Transesophageal, Intra-operative, and Neurosurgical
Product codes (comma separated list FDA assigned to the subject device)
90 IYO
Device Description
The LOGIQ 500 diagnostic ultrasound system with the described modifications is intended for general radiological and cardiac use and consists of a mobile console 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 and pregnant uterus, breast, testes, thyroid, internal abdominal organs
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
DEC 22 1997
510(k) Summary of Safety and Effectiveness: GE LOGIQ 500
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:
March 10, 1997
Product Identification: GE LOGIQ 500 Diagnostic Ultrasound System with 3D and with neurosurgical intended use.
Marketed Devices: The GE LOGIQ 500 Diagnostic Ultrasound System with the described modifications is of a comparable type and substantially equivalent to the ATL HDI 3000 and GE Medical Systems LOGIQ 500 diagnostic ultrasound systems. 510(k) Number K933202, currently in commercial distribution:
Device Description: The LOGIQ 500 diagnostic ultrasound system with with the described modifications is intended for general radiological and cardiac use and consists of a mobile console 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 500 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. Specific intended uses include Abdominal, Peripheral Vascular, OB/Gyn, Small Parts, Musculoskeletal, Urology, Neonatal, Cardiac, Fetal Doppler, Biopsy, Transrectal/transvaginal, Transesophageal, Intra-operative, and Neurosurgical
Comparison with Predicate Device: The GE LOGIQ 500 with 3D is comparable in key safety and effectiveness features, uses the same design, construction, and materials, and has the same features, 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 500 with the described modifications 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 and Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight, with three human profiles incorporated into the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 1997
David Duersteler Safety/Regulatory Project Engineer GE Medical Systems P. O. Box 414 Milwaukee, WI 53201
Re: K970901
LOGIQ 500 Ultrasound System Dated: November 18, 1997 Received: November 19, 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 LOGIO 500 Ultrasound System, as described in your premarket notification:
| Transducer Model Number | |||||
|---|---|---|---|---|---|
| 546L | C364 | C386 | C551 | C721 | CWD2 |
| E772 | 1739 | 739L | L764 | T739 | CWD5 |
| S220 | S316 | S317 | S611 | B510 |
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, 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,
f
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 within a circular shape. The logo is black and white.
Page 1 of 1 Ultrasound Device Indications Statement
510(k) Number (if known): K933202
Device Name: LOGIQ 500 C364 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 | X | X | X | X | X | X | X | |||
| Small Organ | X | X | X | X | X | X | X | |||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | X | X | X | X | X | X | X | |||
| 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. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(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)
10
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970901
4
Image /page/4/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 letters are stylized and have a classic, vintage appearance, and the logo is black and white.
Page 1 of 1 Ultrasound Device Indications Statement
510(k) Number (if known): K933202 Device Name: LOGIQ 500 C386 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 | X | | | | | | | | | |
| Fetal and other | X | X | X | X | X | X | X | | X | |
| Abdominal | X | X | X | X | X | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | X | X | X | X | X | X | | X | |
| Small Organ | | 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 | | | | | | | | | | |
Mode of Operation
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and other includes urological. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(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)
(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological Devic 510(k) Number
5
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular frame. The frame has a decorative, swirling pattern around the letters.
Page 1 of 1
510(k) Number (if known): K933202 Device Name: LOGIQ 500 C551 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 | X | ||
| Musculoskeletal | ||||||||||
| Intra-operative | ||||||||||
| Neurosurgical | ||||||||||
| Pediatric | X | X | X | X | X | X | X | |||
| Small Organ | X | X | X | X | X | X | X | |||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | X | X | X | X | X | X | X | |||
| 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. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(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)
Dillon fully
(Division Sign Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
6
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are solid black, contrasting with the white background.
Page 1 of 1 Ultrasound Device Indications Statement
510(k) Number (if known): K933202 Device Name: LOGIQ 500 C721 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 | ||||||||||
| Abdominal | ||||||||||
| Musculoskeletal | ||||||||||
| Intra-operative | ||||||||||
| Neurosurgical | X | |||||||||
| Pediatric | X | X | X | X | X | X | ||||
| Small Organ | X | |||||||||
| Neonatal | X | 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 | ||||||||||
| Laparoscopic |
Mode of Oneration
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and other includes urological. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(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)
Kimberly
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number
7
Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.
Ultrasound Device Indications Statement
Page 1 of 1
510(k) Number (if known): K933202 Device Name: LOGIQ 500 E721 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 | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardic Pediatric | | | | | | | | | | |
| Trans- | | | | | | | | | | |
| esophageal | | | | | | | | | | |
| Trans-rectal | | X | × | × | X | X | X | | × | |
| Trans-vaginal | | 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. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ray Ambra fuccia
(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
8
Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized, cursive font. The intertwined letters are enclosed within a circular border, creating a distinctive and recognizable emblem for the company.
Page 1 of 1
510(k) Number (if known): K933202 Device Name: LOGIQ 500 1739 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 | ||||||||||
| Abdominal | ||||||||||
| Musculoskeletal | ||||||||||
| Intra-operative | X | X | X | X | X | X | X | |||
| Neurosurgical | X | X | X | X | X | X | X | |||
| Pediatric | ||||||||||
| Small Organ | 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 | ||||||||||
| Laparoscopic |
Mode of Operation
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and other includes urological. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K970901
9
Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The letters and border are black, contrasting with the white background.
Page 1 of 1
510(k) Number (if known): K933202 Device Name: LOGIQ 500 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:
| | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|-------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Clinical
Application | | | | | | | | | | |
| Opthalmic | | | | | | | | | | |
| Fetal and other | X | X | X | X | X | X | X | | X | |
| Abdominal | X | X | X | X | X | X | X | | X | |
| Musculoskeletal | X | X | X | X | X | X | X | | X | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | X | 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 | | X | |
| Laparoscopic | | | | | | | | | | |
Mode of Operation
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and other includes urological. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
(Division Sigh-Off)
Division of Reproductive, Abdominal, ENT, Division: on of the Devi 510(k) Number .
10
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Page 1 of 1
510(k) Number (if known): K933202 Device Name: LOGIQ 500 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 | | X | |
| Abdominal | | | | | | | | | | |
| Musculoskeletal | | X | X | X | X | X | X | | X | |
| Intra-operative | | X | X | X | X | X | X | | X | |
| Neurosurgical | | X | X | X | X | X | X | | X | |
| Pediatric | | X | X | X | X | X | X | | X | |
| Small Organ | | 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 | | 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. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(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)
사내
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
K970901
510(k) Number
11
Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular shape. The letters are stylized and appear to be handwritten. The logo is black and white.
Ultrasound Device Indications Statement
Page 1 of 1
510(k) Number (if known): K933202 Device Name: LOGIQ 500 L764 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 | | X | X | X | X | X | X | | X | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | 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 | | 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. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. W
(Division Sign Off) Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number
12
Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized manner. The letters are surrounded by a circular shape with a swirling pattern, giving the logo a dynamic and recognizable appearance.
Page 1 of 1
510(k) Number (if known): K933202 Device Name: LOGIQ 500 T739 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 | ||||||||||
| Abdominal | ||||||||||
| Musculoskeletal | ||||||||||
| Intra-operative | X | X | X | X | X | X | X | |||
| Neurosurgical | X | X | X | X | X | X | X | |||
| Pediatric | ||||||||||
| Small Organ | 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 |
Mode of Operation
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and other includes urological. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT.
and Radiological Devices
510(k) Number K970901
13
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters and border are in black, contrasting with the white background.
Page 1 of 1
510(k) Number (if known): K933202 Device Name: LOGIQ 500 S220 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 | | X | X | X | X | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | X | X | X | X | | X | |
| Cardiac Pediatric | | X | 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. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dallam for LAY
(Division Sign-Off) Division of Reproductive, Abdominal, BNT and Radiological Deyice 510(k) Number
14
Image /page/14/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, with the letters and the circle being black and the background being white.
Page 1 of 1
510(k) Number (if known): K933202 Device Name: LOGIQ 500 S316 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 | | X | X | X | X | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | X | X | X | X | | X | |
| Cardiac Pediatric | | X | 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. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Keing Kimber fon lly
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number
15
Image /page/15/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 letters and the circle are black, creating a strong contrast against the white background.
Page 1 of 1
510(k) Number (if known): K933202 Device Name: LOGIQ 500 S317 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 | | X | X | X | X | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| 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 Operation
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and other includes urological. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. R970901
16
Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular frame. The letters are stylized and appear in a bold, sans-serif font. The logo is black and white.
Page 1 of 1
510(k) Number (if known): K933202 Device Name: LOGIQ 500 S611 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 | | | | | | | | | X | | |
| Pediatric | | X | X | X | X | X | X | X | | | |
| Small Organ | | | | | | | | | | X | |
| Neonatal | | X | X | X | X | X | X | X | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | X | X | X | X | X | X | X | | X | |
| Cardiac Pediatric | | X | X | X | X | X | X | X | | X | |
| Trans- | | | | | | | | | | | |
| esophageal | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
Mode of Operation
Laparoscopic
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and other includes urological. 1 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------Intra-operative includes internal abdominal organs.
Intra-operative modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(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)
(Division Sign-Off)
Vision Sign-Off) Vision of Reproductive, Abdominal. ENT. and Radiological De 310(k) Number
17
Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized and appear to be hand-drawn or calligraphic.
Page 1 of 1
510(k) Number (if known): K933202 Device Name: LOGIQ 500 B510 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 | ||||||||||
| Abdominal | ||||||||||
| Musculoskeletal | ||||||||||
| Intra-operative | ||||||||||
| Neurosurgical | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardic Pediatric | ||||||||||
| Trans-esophageal | X | X | X | X | X | X | X | X | ||
| 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. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
§10(k) Number K970901
18
Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and have a vintage or classic appearance. The logo is black and white.
Page 1 of 1
510(k) Number (if known): K933202 Device Name: LOGIQ 500 CWD2 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 | ||||||||||
| Abdominal | X | X | X | X | X | X | X | |||
| Musculoskeletal | ||||||||||
| Intra-operative | ||||||||||
| Neurosurgical | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | X | X | X | X | X | X | X | |||
| Cardiac 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. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive. Abdominal, ENT,
and Radiological Devices
510(k) Number K970901
19
Image /page/19/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.
Page 1 of 1
510(k) Number (if known): K933202 Device Name: LOGIQ 500 CWD5 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 | ||||||||||
| Abdominal | ||||||||||
| Musculoskeletal | ||||||||||
| Intra-operative | ||||||||||
| Neurosurgical | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| 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 | X | |||
| Laparoscopic |
Mode of Operation
Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and other includes urological. Intra-operative includes internal abdominal organs.
Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K970901