(426 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or training/test sets for algorithms. The description focuses on standard ultrasound imaging capabilities.
No
The device is described as a "real-time two-dimensional diagnostic ultrasound imaging" system, indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "The HRT2000 system...enables real time two dimensional diagnostic ultrasound imaging." and "Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:".
No
The device description explicitly states "The HRT2000 system connected with a probe enables real time two dimensional diagnostic ultrasound imaging." and "The system offers optional probes". This indicates the device includes hardware components (probes) in addition to any potential software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the HRT2000 system is for real-time two-dimensional diagnostic ultrasound imaging of the human body directly, not on samples taken from the body.
- The description focuses on imaging internal anatomy. The listed anatomical sites (abdominal, small organ, gynecological, urological, vascular, cardiac) are all internal structures imaged directly within the patient.
Therefore, the HRT2000 system is a diagnostic imaging device, specifically an ultrasound system, and not an IVD.
N/A
Intended Use / Indications for Use
The HRT2000 system connected with a probe enables real time two dimensional diagnostic ultrasound imaging. The system offers optional probes each type optimized to image structure and orienation of tissues during specific opinical applications. These include general abdominal, small organ, gyneeological and urological, vascular and cardiac anatomy.
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
For CLI 7900 GP 3.5 MHz Probe: Abdominal, Cardiac Adult, Cardiac Pediatric
For CLI 4000 TV 6.5 MHz Probe: Abdominal, Trans-vaginal
For CLI 5000 TR 6.5 MHz Probe: Trans-rectal
For CLT 6000 PV 12.5 MHz Probe: Small Organ, Peripheral vessel
Product codes
90 IYO
Device Description
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 Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number | | |
---|---|---|---
GA-3.5 | (CLI 7900) | 3.5 MHz | General Purpose
TV-6.5 | (CLI 4000) | 6.5 MHz | Transvaginal
TR-6.5 | (CLI 5000) | 6.5 MHz | Transrectal
PV-12.5 | (CLI 6000) | 12.5 MHZ | Peripheral Vascular
The HRT2000 system connected with a probe enables real time two dimensional diagnostic ultrasound imaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
General abdominal, small organ, gyneeological and urological, vascular and cardiac anatomy.
Abdominal, Cardiac Adult, Cardiac Pediatric, Trans-vaginal, Trans-rectal, Small Organ, Peripheral vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1997
Raul Gutierrez, R.T., R.D.M.S. President International Ultrasound Corporation 14 West Forest Avenue Englewood. NJ 07631
Re: K961229 HRI 2000 Ultrasound System Dated: March 28, 1997 Received: March 28, 1997 Regulatory class: II 21 CFR 892,1560/Procode: 90 IYO
Dear Mr. Gutierrez:
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 Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
| GA-3.5 | (CLI 7900) | 3.5 MHz | General Purpose |
|---|---|---|---|
| TV-6.5 | (CLI 4000) | 6.5 MHz | Transvaginal |
| TR-6.5 | (CLI 5000) | 6.5 MHz | Transrectal |
| PV-12.5 | (CLI 6000) | 12.5 MHZ | Peripheral Vascular |
1
Page 2 - Raul Gutierrez
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 for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations. 21 CFR. Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's February 17, 1993 "Revised 510(k) Diagnostic Ultrasound Guidance for 1993." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-40) 9200 Corporate Boulevard Rockville, Marvland 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 - Raul Gutierrez
መልከተማ የሚያስደድ የአማርኛ ምሳሌ ነው።
and the finitiation of the program and the comments of the seat and the seat a
Comments of the first to the state of the comments of the management of the many of the many of the many of the may be
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ﺗﻘﺮﻳﺮ ﺍﻟﻤﺮﺍﺟﻊ
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 Paul Gammell, Ph.D. at (301) 594-1212.
Sincerely yours,
for
Lilli
Dire
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Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation
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3
510(k) Number (if known): K961229
Device Name: HRI2000 Ultrasound System
ndications For Use:
The HRT2000 system connected with a probe enables real time two dimensional diagnostic ultrasound imaging. The system offers optional probes each type optimized to image structure and orienation of tissues during specific opinical applications. These include general abdominal, small organ, gyneeological and urological, vascular and cardiac anatomy.
(PLEASE DO NOT WRITE RELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109)
ੁਸ਼
Over-The-Couator Use
(Optional Formal 1-2-96)
ﺗﺒﺎﺭﻳﺲ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﺘﻮ
Vainl. A. Severson
(Division Sign-Off) Division of Reproductive, Abdominal. ENT, and Radiological Dev 510(k) Number
4
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| 510(k) Number (if known): | K961229 |
|---|---|
| Device Name: | CLI 7900 GP 3.5 MHz Probe |
Fill out one form for each ultrasound system or transducer.
Diagnostic ultrasound imaging or Doppler analysis of the Indications For Use: human body as follows: Hode of Operatitees
| Clinical
Application | A | B | H | M | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|------------------------------|---|---|---|---|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | X | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | | | | | | | | |
| Cardiac
Pediatric | | X | | | | | | | | |
| Trans-
esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
CONTINUE ON ANOTHER PAGE IF NEBORD (PLEABER DO NOT HOTER DETON TITS LEAR 61 5 GET 300 17. Care Ista Elon (((1) == ) a of
Prescription Use (Fer 21 CPR 801.109)
Klim G. Degner
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
5
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FAX NO. 2018168777
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| 510(k) Number (if known): | K961229 |
|---|---|
| Device Name: | CLI 4000 TV 6.5 MHz Probe |
Pageour one form for each ultrasound system or transducer. געוו
Diagnostic ultrasound imaging or Doppler analysis of the Indications For Use: Tuman body as follows: Hode of Operacious
| Clinical Application | A | B | FMD | CMD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | ✓ | ||||||||
| Intra-operative (Specify) | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | X | ||||||||
| Intra-luminal | |||||||||
| Trans-urethral | |||||||||
| Peripheral vessel | |||||||||
| Laparoscopic |
Other Indications or Modes:FLEASE DO NOT HOT WATER 6333
Prescription Use (Per 21 CFR 801.109)
David A. Segner
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices 510(k) Number
6
นี้ษั้น--08--87 คีร้า อัล--85
| 510(k) Number (if known): | K961129 |
|---|---|
| Device Name: | CLI 5000 6.5 MHz Probe |
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 με Operation
| Clinical
Application | R | N | M | FWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac
Pediatric | | | | | | | | | | |
| Trans-
esophageal | | | | | | | | | | |
| Trans-rectal | | | X | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
FACE TELEVER DO ADE WATER BEYON THIS LEAST OF DELLOS OF DEALERS OF DEALERS
Prescription Use (Per 21 CPR 801.109)
大发生
Damil A. Seymm
1 (Uivision Sign-Off)
(Division of Reproductive, Abdominal, ENT,
Division of Reprodetive, Abdominal, ENT,
and Radiological Devision, Abdominal, ENT,
510(k) Number 510(k) Number
ﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
7
INTL ULTRASOUND 97 FRI 03:42 PM
ﻪ ﺗ
Page ರ್
510(k) Number (if known) CLT 6000 Device Name :_________________________________________________________________________________________________________________________________________________________________
ີສອນອຸດສາມອິດ ແລະລັດ. aach altrascund syst Fill out one form for
Diagnostic ultrasound imaging or Doppler analysis of the Indications For Use:
human body as follows: E Aprimes 2016
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Focal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | X | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac
Pediatric | | | | | | | | | | |
| Trans-
esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
vessel | | X | | X | | | | | | |
| Laparoscopic | | | | | | | | | | |
FLEASE DO ACE WRITE BETAN
Prescription Use (Fer 21 CPR 601.109)
David A. Segerson
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT. and Radiological Device 510(k) Number