(107 days)
The Ultrasonix Ergosonix 500 is intended for use in obstetrics/gynecology, general radiology examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), transvaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric).
The Ultrasonix Ergosonix 500 Ultrasound Diagnostic Scanner is highly mobile, software-controlled, diagnostic ultrasound system capable of the following operating modes: 2D B-mode, M, Pulsed Doppler, Color Flow (including amplitude Doppler). The system can generate real-time compound images and harmonic images. The system is designed for use in linear and convex scanning modes, and supports linear, convex, and microconvex probes.
This document is a 510(k) Pre-market Notification for the Ultrasonix Ergosonix 500 Ultrasound Scanner. It seeks to demonstrate substantial equivalence to previously cleared predicate devices (ATL HDI 5000 System (K002003) and Acuson Sequoia (K973767)).
The document does not describe "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the typical sense of a clinical performance study with defined metrics for a novel AI device. Instead, it focuses on demonstrating safety and substantial equivalence to predicate ultrasound devices for various clinical applications and imaging modes.
Here's an analysis based on the provided text, addressing the requested information where applicable:
1. A table of acceptance criteria and the reported device performance
The document does not define specific performance acceptance criteria in terms of sensitivity, specificity, accuracy, or other statistical measures typically associated with AI/CADe devices. The "acceptance criteria" for this conventional ultrasound device are implicitly its compliance with recognized safety and performance standards and its substantial equivalence to predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Compliance with EN 60601-1, UL 2601-1, C22-2 No 601-1, EN 60601-1-2, IEC 60601-2-37, AIUM "Acoustic Output Labeling Standard", AIUM "Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices" | The Ultrasonix Ergosonix 500 is "designed to comply" with all listed standards. |
| Acoustic output limits compliance with NEMA UD-3 and 510(k) Diagnostic Ultrasound Guidance (September 30, 1997 revision) | Acoustic output limits reported as: ISPTA: 720mW/cm2 TIS/TIB/TIC: 0.1 - 4.0 (Range) Mechanical Index (MI): 1.9 (Maximum) ISPPA: 0-700 W/cm2 (Range) These limits are stated to be "the same as predicate Track 3 devices." |
| Substantial equivalence in intended use, principles of operation, and technological characteristics to predicate devices. | Stated to be "substantially similar" and "operates identically" in principle, with similar hardware and parameters for image quality. Differences noted in "more innovative" programmable system made of 2 building blocks. |
| Intended Use approval for specified clinical applications (Obstetrics/Gynecology, General Radiology, Abdominal, Small parts, Peripheral Vascular, Musculo-skeletal (conventional & superficial), Cephalic (pediatric & adult), Small organ (breast, thyroid, testicle), Transvaginal, Trans-rectal, Pediatric, Fetal imaging, Cardiac (adult & pediatric)) across various modes (B, M, PWD, CD, AD, CVI, Combined, other). | The "Diagnostic Ultrasound Indications for Use Form" (pages 6-9) indicates the system and its transducers (4C1, L7, EC6.5/128) are cleared for a broad range of clinical applications and imaging modes, largely marked with "P" (previously cleared by FDA) or left blank where it implies standard capability. The specific mode availability varies slightly per transducer as detailed in the forms. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not involve a "test set" in the context of clinical data for algorithmic performance evaluation. It's for a conventional ultrasound device, where equivalence is primarily demonstrated through engineering specifications, compliance with standards, and comparison of technical characteristics and intended uses to predicate devices. Therefore, the concept of sample size and data provenance for a test set is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as there is no "test set" requiring ground truth establishment by experts for algorithmic performance evaluation. The review process by the FDA involves their own experts assessing the submitted documentation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" or adjudication of diagnostic outputs from an algorithm.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a submission for a standalone ultrasound imaging system, not an AI-assisted diagnostic or CADe device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or detailed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone diagnostic ultrasound imaging system. It produces images and physiological data that are interpreted by a qualified physician. There is no AI algorithm being submitted for standalone performance evaluation in the context of this 510(k).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As this is a conventional ultrasound system, performance is established through technical validation against standards and comparison to predicate devices, rather than through clinical studies requiring a ground truth for diagnostic accuracy.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm or system that requires a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as above.
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KO20630
510(k) Summary for the Ultrasonix Ergosonix 500 Ultrasound Scanner
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Devices Act of 1990 revisions to 21 CFR, Part 807.92, Content and format of a 510(k) Summary.
1.0 Submitter Information
JUN 1 3 2002
1.1 Submitter:
Ultrasonix Medical Corporation 535 - 2660 Oak Street Vancouver, British Columbia Canada. V6H 3Z1
Contact: 1.2
Ken Seto Quality Assurance / Regulatory Engineer ken@ultrasonix.com (604) 875 — 4985
Other Contact:
Laurent Pelissier Chief Technical Officer laurent@ultrasonix.com (604) 875 — 5295
1.3 Date prepared:
February 20 2002
2.0 Device Name
2.1 Common Name:
Ultrasound Imaging System
2.2 Proprietary name:
Ultrasonix Ergosonix 500 Ultrasound Scanner
2.3 Classification Name:
| FR Number | Product Code | |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
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Classification: 2.4
Class II
Predicate Device: 2.5
ATL HDI 5000 System (K002003) Acuson Sequoia (K973767)
2.6 Reason for submission:
New product
3.0 Device Description
The Ultrasonix Ergosonix 500 Ultrasound Diagnostic Scanner is highly mobile, software-controlled, diagnostic ultrasound system capable of the following operating modes: 2D B-mode, M, Pulsed Doppler, Color Flow (including amplitude Doppler). The system can generate real-time compound images and harmonic images.
The system is designed for use in linear and convex scanning modes, and supports linear, convex, and microconvex probes.
| Frequency Range | 2-15MHz |
|---|---|
| Transducer types | Linear arrayCurved arrayIntracavitary array |
The Ultrasonix Ergosonix 500 is designed to comply to the following standards:
·EN 60601-1: European Norm, Medical Electrical Equipment •UL 2601-1: Underwriters Laboratories Standards, Medical Electrical Equipment
·C22-2 No 601-1. Canadian Standards Association. Medical Electrical Equipment ·EN 60601-1-2 : European Norm, Collateral Standard, Electromagnetic Compatibility • EC 60601-2-37: Particular requirements for the safety of ultrasonic medical diagnostic equipment ·AIUM "Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment" Jan 1998 •AIUM "Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices"
Summary of Intended Uses 4.0
The Ultrasonix Ergosonix 500 is intended for use in obstetrics/gynecology, general radiology examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), transvaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric).
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Comparison to Predicate Device 5.0
The Ultrasonix Ergosonix 500 diagnostic ultrasound scanner is substantially equivalent to the predicate devices with respect to intended use / indications for use, principles of operation and technological characteristics.
6.0 Technological Characteristics
The technological characteristics are substantially similar to that of the predicates. The device operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D or M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler) are the same as a the predicate devices identified in item 2.5. Transducer patient contact materials are biocompatible.
The beam forming architecture is very similar to that of the predicate devices. The receiving and processing hardware is similar but more innovative in that it is a programmable system made of 2 building blocks, which can be reconfigured to operate the system in any imaging mode.
The parameters used to adjust image quality are the same as that seen in the predicates. This includes the use of TGC gain sliders, depth control, base control and angling, among others.
7.0 Safety Considerations
As a track 3 ultrasound device, the Ultrasonix 500 Ultrasound Diagnostic Scanner is designed to comply with the 'Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (1992)" published by the National Electrical Manufacturers Association as UD -3.
With respect to limits on acoustic outputs, the Ultrasonix 500 Ultrasound diagnostic scanner complies with the guideline limits set in the September 30, 1997, Revision of 510(k) Diagnostic Ultrasound Guidance.
With regard to general safety, the Ultrasonix Ergosonix 500 Ultrasound diagnostic scanner is designed to comply with IEC 601-1(1988) Medical Electrical Equipment, Part 1: General Requirements for Safety, and IEC 60601 - 2-37: Particular Requirements For The Safety Of Ultrasonic Medical Diagnostic And Monitoring Equipment.
The device's acoustic output limits are:
| ISPTA (d) | 720mW/cm2 |
|---|---|
| TIS/TIB/TIC | 0.1 - 4.0 (Range) |
| Mechanical Index (MI) | 1.9 (Maximum) |
| ISPPA (d) | 0-700 W/cm2 (Range) |
The limits are the same as predicate Track 3 devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2002
Mr. Ken Seto Ouality Assurance / Regulatory Engineer Ultrasonix Medical Corp. Jack Bell Research Centre 535 - 2660 Oak St. VANCOUVER BC CANADA V6H 3Z6
Re: K020630
Trade Name: Ultrasonix Ergosonix 500 Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYN and IYO Dated: May 3, 2002 Received: May 10, 2002
Dear Mr. Seto:
We have reviewed your Section 510(k) premarket 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 legally marketed predicate 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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Ultrasonix 500 Ultrasound Scanner, as described in your premarket notification:
Transducer Model Number
4C1 Transducer L7 Transducer EC6.5 / 128 Transducer
Image /page/3/Picture/12 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of a bird with three human profiles incorporated into the design.
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer 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".
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Page 3 - Mr. Seto
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Daniel A. Dyson
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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The Ergosonix 500 System
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | િય | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify)* |
| Ophthalmic | ||||||||||
| Fetal | ﺗﻤﻜﻴﺔ ﺗﺴﻤﻴﺔ | ma are | ﻟﻤﺤﺘﻮﻓﻲ ﺍﻟﻤﺴﺘﻘﻠﻲ ﺍﻟﻤﺴﺘﻘﻠﻲ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤ | |||||||
| Abdominal | ﺗﺤﻘﻴﻘﺎ ﺗﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ | Support Fridge States Company Company Company Company Company Company Company Company Company Company Company Company Company Comments Comments Comments of Children Comments | ﻣﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ | |||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatnc | ﺗﻘﺮﻳﺒﺎ ﺗﻘﺮﻳﺒﺎ ﺗ | مڪندڙ آهن. | ||||||||
| Small Organ (specify) | ميٽرمٽ ميٽرمٽ | ﻟﻤﻜﺘﺐ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ | ﻣﺘﻌﺪﺩ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ | - 3 - 2 | ||||||
| Neonatal Cephalic | - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | مستمبر آهي. منتشمر آهي ته ا | ممكنية تسمير المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى ا | 1500 | Support September 1998 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 19 | |||||
| Adult Cephalic | 13 | مقارم محمد معتقد معتقد معاشرة من المقارمة المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المس | ﻛﺮ ﻛﺮﺓ ﻛﺮ | The property | and the province of the proposition of the program and the program and the program and the production of the first and the first and the first and the first and the first and | |||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | سمحمد بلادة مستخدم من المستخدم المستخدم المستخدم المستخدم المستخدم المستخدم المستخدم المشاهدة المستخدم المستخدم المستخدم المستخدم المشاهدة المستخدم المستخدم المستخدم المستخدم | مستور آهي. وقترار آهي | 13 | 1 - 1 - 1 | ||||||
| Transvaginal | ﺗﺤﻤﻴﺮ ﺗﻜﺴﻜﺮﻳﻢ | ﻛﺘﻴﺮ ﺑﺎﺳﻢ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ | مجمعة من جميع المحمول المحمول المحمول المحمول المحمول المحمول المستمر المنتخب المحمول المستقل المستقل المحمول المستقل المحمول المستقل المحمول المستقل المحمول المستقل المحمول | ్లాల్లో ప్రభావాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీల | ||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | 1 | ﮐﺴﺮ ﭘﺎﮐﺴﺘﺎ | سمحمد الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع | ್ಕೆ ಸ್ಟ್ರಾನ್ಸ್ ಸ್ಟ್ರೀಕ್ಷಿಸಿದ್ದ | ﻛﺘﻮﺑﺮ ﺃﻣﺮﻳﻜﺎ ﻓﻲ ﻣﺴﺘﻮﻯ ﺍﻟﺴﻴﺎﺭﺍﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ | مستقبرة ا | تحميرة ست | Separate " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " | ||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ﺷﻬﺪ ﻗﺮﻳﺒﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ | 1 | 135 | ﻟﻘﺎﺑﺔ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ | Franch | ﺗﻘﺮﻳﺒﺔ ﻣﻦ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ | "",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""" | |||
| Musculo-skeletal Superficial | - 335 | ﻳﺘﺮ ﺇﻟﻰ | ﺑﻜﺮ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ | تم سمي آهي. م | تحتيم په سان | Spany Super | Spanish | ﻣﻌﺘﻘﺪ ﺗﻢ ﺗﻌ | ||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:__________________________________________________________________________________________________________________________________________________________
Small parts: thyroid, breast, testicles, etc ... I
*1: B&M, B&PWD, B&CD&PWD, B&CD, B&AD, B&AD&PWD
*2: Compound Imaging (BX), Tissue harmonic imaging
Tissue Harmonic is an option in B mode, not an actual scanning mode.
(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. Harper
(Division Sign-Off) Division of Reproductive, A and Radiological Device E-3 510(k) Numbe
{7}------------------------------------------------
Ergosonix 500 and 4C1 Transducer
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | متمير آهي. متحدث ت | ﻟﻜﻤﻴﻨﻴﻮﻧﻴﺔ ﺍﻟﻤﺴﺘﻮﻳﺘﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ | ﻣﺘﻨﻴﺮ ﺗﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ | Status Carana | Transal | April 2017 - 12:40 PM IST - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 1 | Transport | |||
| Abdominal | ﺗﻜﺴﻬﺮ ﺗﻢ ﺗﻜﺮﻳﻢ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ | محمدر الممثلات الممثلة الممثلة المستوى المستوى المستوى المستوى المستوى الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموق | September 1998 | |||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | متعدد المتعدد المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى | مستقليم تحقيق تش | مڪمرٽ سم | محمد محمد منهم الحمير من المحمد الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع ال | ممتعدد المشكرية المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستو | مختلف المقتلم المقتلبة المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستو | 125555565688888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888 | Article Property | ||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:__________________________________________________________________________________________________________________________________________________________
*1: B&M, B&PWD, B&CD&PWD, B&CD, B&AD, B&AD&PWD
*2: Compound Imaging (BX), Tissue harmonic imaging
Tissue Harmonic imaging is an option in B mode, not an actual scanning mode.
(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, and Radiological Devices 510(k) Number -
F-3
{8}------------------------------------------------
Ergosonix 500 and L7 Transducer
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | Transmit | ﺗﻘﺮﻳﺒﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺮ | ﻟﻠﻘﻴﺔ ﺍﻟﻤﺴﺎ | - 2000 | " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " | |||||
| Abdominal | 1.50 | ﻣﻜﺘﺒﺔ ﺗﺴﻤﻰ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ | ﻣﺤﻤﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ్లో ప్రజల్లో ప్రస్సుల్ ప్రస్సుల్ స్టేషన్లు వైద్యశాలలు | |||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ﺷﻬﺮ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ | |||||||||
| Small Organ (specify) | - 33800 | ﺘﺤﻘﻴﻘﺔ | ||||||||
| Neonatal Cephalic | ﻟﻤﺴﺘﺸﻔ | ﺷﺘﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ | محمد المحميرة المحمولة المستقل المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى | محموبة محموبة من من المحموم الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع | ||||||
| Adult Cephalic | محمد والمحميرية والتقليم المحمولية المستخدم والتقاريخ الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع ا | ﺷﻬﺮ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﺮﺍﺗﻴﻢ ﺍﻟﻤﺘﺮﺍﺗﻴﻢ ﺍﻟﻤﺘﺮﺍﺗﻴﺔ ﺍﻟﻤﺘﺮﺍﺗﻴﺔ ﺍﻟﻤﺘﺮﺟﻤﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﺮﺗﺒﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﺮﺗﺒﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ | 1 2 25 | The first | ﺷﻬﺮ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻘ | |||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ﻟﺘﻲ ﺗﺄﺳﻴﺴﺎﺕ ﺳﻨﺔ 1990 ﻓﻲ ﺇﺳﺒﺎﻧﻴﺎ ﻓﻲ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ | متحرف المتحدة المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى | The Property | ﻧﻜﺮ ﺗﺮﺗﺒﻪ ﺳﻴﺴﺎ | مختلفة المحمد المشتمل المشتمل المستقل المستقل المستقل المستقل المستقل المستقل المستقل المستقل المستقل المستقل المستقل المستقل المستقل المستقل المستقل المستقل المستقل المستقل | ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ﻗﺎﺋﻢ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻘﻊ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ | ﻣﺤﺘﻤﺮﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﻘﻖ ﺍﻟﻤﺴﺘﻤﺮ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴ | مختلبة من منتجمة المحتمية المحتمية المحتمية المحتمية المستقل المستخدم المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى | ﺗﺘﺤﻘﻴﻘﺔ | 1 255 | ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ | ||||
| Musculo-skeletal Superficial | ﻟﻌﻤﺮ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮ | ﺷﻬﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ | 14 | ﺗﺸﻴﺘﻴﺔ ﺃﻣﺮﻳﻜﺎ | State | مکستان کے شہر | Parting States | |||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Small parts: thyroid, breast, testicles, etc ...
*1: B&M, B&PWD, B&CD&PWD, B&CD, B&AD, B&AD&PWD
*2: Compound Imaging (BX), Tissue harmonic imaging
Tissue Harmonic Imaging is an option in B mode, not an actual scanning mode.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
F-3
Prescription Use (Per 21 CFR 801.109)
David A. Segura
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number -
{9}------------------------------------------------
Appendix F ·
Ergosonix 500 and EC6.5 / 128 Transducer
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | ત્ત | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify)** |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ﺗﻤﺘﻊ ﺩﺭﺍﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ | مترجم آهي. منتشم | مسمجموعة من المحمد الأمريكية المستقى المنتقى المنتقى المنتقى المنتقى المنتقى المنتقى المنتقى المنتقى المنتقى المنتقى المنتقى المنتقى المنتقى المنتقى المنتقى المنتقى المنتقى ا | ﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺘﺤﺪﺓ | ﻣﺮﻛﺒﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ | سمبر سمبر سم | 12 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 55 | |||
| Transvaginal | ﻟﻤﺘﺤﻘﻖ ﻓﻲ ﺗﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ | "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "", "" | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Amarkan Arabaran Arabaran Arabara Araban Araban Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana Ana An | ﻣﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ | سمت آهن | مسمسم محمد المشاركة من المستمرة المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستق | ﺃﺷﻬﺮ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ | ||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Penpheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
*1: B&M, B&PWD, B&CD&PWD, B&CD, B&AD, B&AD&PWD
*2: Compound Imaging (BX), Tissue harmonic imaging
Tissue Harmonic is an option in B mode, not an actual scanning mode.
(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. Syverson
(Dıvision Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
F-3
§ 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.