(81 days)
The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parotid, submaxillary gland, testes and breast.). Peripheral Vascular, Transvaginal, Transrectal, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology.
The CHISON iVis20/iVis30/i3/ Q1/Q2/Q3/Q5 ultrasound system is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The CHISON ultrasound system can be configured as a roll-around model on wheels (iVis20/iVis30/i3/ Q1/Q2/Q3/Q5). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems which have been available in the market for years. This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes.
Acceptance Criteria and Study for CHISON iVis Series & Q Series, i3 Diagnostic Ultrasound Systems
This document describes the acceptance criteria and study information for the CHISON iVis Series & Q Series, i3 Diagnostic Ultrasound Systems, extracted from the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) premarket notification summary. For medical devices seeking substantial equivalence, performance characteristics are typically compared against an existing "predicate device" rather than predefined numerical acceptance criteria in the same way as an AI/ML device. The "acceptance criteria" here are implicitly that the new device performs comparably to the predicate device, GE Voluson E6/E8/E8 Expert (K101236), across various imaging modes and clinical applications.
The reported device performance is that the CHISON iVis Models and Q Models and i3 are "substantially equivalent in safety and effectiveness" to the predicate. This equivalence is based on the systems having the "same intended uses and basic operating modes," "same gray-scale and Doppler capabilities," and acoustic output levels "below the applicable FDA limits."
The 510(k) summary itself does not contain specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for image quality or diagnostic effectiveness, as would often be the case for AI/ML devices or novel technologies. Instead, the focus is on demonstrating that the new device meets the same safety and performance standards as the predicate device already on the market.
Table: Comparison to Predicate Device (Implied Acceptance Criteria)
| Feature/Performance Aspect | Acceptance Criteria (Comparable to Predicate: GE Voluson E6/E8/E8 Expert (K101236)) | Reported Device Performance (CHISON iVis Series & Q Series, i3) |
|---|---|---|
| Intended Uses | Same as predicate device | Same as predicate device |
| Basic Operating Modes | Same as predicate device (B-Mode, M-Mode, Pulsed Doppler, Color Doppler, Power Doppler, Directional Power Doppler) | Same as predicate device |
| Gray-scale Capabilities | Comparable to predicate device | Same capabilities as predicate device |
| Doppler Capabilities | Comparable to predicate device | Same capabilities as predicate device |
| Acoustic Output Levels | Below applicable FDA limits | Below applicable FDA limits |
| Product Safety Standards | Compliance with relevant standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1) | Designed to meet listed product safety standards |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective study design).
The submission is for a diagnostic ultrasound system aiming for substantial equivalence to a predicate device. This type of submission typically relies on device design specifications, performance testing (e.g., electrical safety, acoustic output, electromagnetic compatibility), and a comparison of technical features and intended uses to the predicate, rather than a clinical study with a "test set" in the context of AI/ML or novel diagnostic algorithms.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Since the 510(k) summary does not describe a clinical study with a test set requiring ground truth established by experts, there is no information provided regarding the number or qualifications of experts for this purpose.
4. Adjudication Method for the Test Set
As there is no mention of a clinical study or a test set requiring expert adjudication for ground truth, no adjudication method is described in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed, nor does it provide any effect size of human readers improving with or without AI assistance. The device is a diagnostic ultrasound system, not explicitly described as incorporating AI for interpretation.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone (algorithm only) performance study. The device is a complete ultrasound system, and its performance is evaluated in the context of its overall functionality and comparison to a predicate device, not as a standalone algorithm.
7. Type of Ground Truth Used
Given the nature of a 510(k) for a diagnostic ultrasound system (not an AI algorithm or a novel diagnostic modality), the concept of "ground truth" in the context of a clinical test set is not directly applicable or described. The submission focuses on demonstrating that the device's technical specifications, imaging capabilities (B-Mode, M-Mode, Doppler), and safety aspects are equivalent to those of a legally marketed predicate device.
8. Sample Size for the Training Set
The provided 510(k) summary does not contain any information about a training set or its sample size. This is consistent with a traditional medical device submission for substantial equivalence, which does not typically involve machine learning model training as a documented component of the submission.
9. How Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied, there is no information on how ground truth for a training set was established.
{0}------------------------------------------------
PREMARKET NOTIFICATION [510(k)] Summary
This Summary of Safety and Effectiveness is prepared in accordance with 21 CFR Part 807.92(c).
1. Company Name:
Chison Medical Imaging Co., Ltd. No.8. Xiang Nan Road. Shuo Fang, New District, Wuxi, China 214142 Chison Medical Imaging Co., Ltd. No.8, Xiang Nan Road, Shuo Fang, New District, Wuxi, China 214142
| Contact: | Ms. Ruoli Mo |
|---|---|
| Tel: +86-510-85311707, 85310593 | Fax: +86-510-85310726 |
U.S. Agent:
Leiker Regulatory & Quality Consulting 7263 Cronin Circle Dublin, CA 94568
Contact: Bob Leiker Tel: (925) 556-1302 Fax: (866) 718-3819
- Device Name: CHISON iVis 20 & iVis 30 & i3 (Rollaround) 2. & Q1&Q2&Q3&Q5Roll (Portable) Diagnostic Ultrasound System
Common/Usual Name: Diagnostic Ultrasound System with Accessories
Classification: Requlatory Class: II Review Category: Tier II
| Classfication Name | 21 CFR Section | Product Code |
|---|---|---|
| Ultrasonic pulsed doppler imaging system | 892.1550 | 90-IYN |
| Ultrasonic pulsed echo imaging system | 892.1560 | 90-IYO |
| Diagnostic ultrasonic transducer | 892.1570 | 90-ITX |
2. Marketed Device:
K101236, GE Voluson E6/E8 /E8 Expert Diagnostic Ultrasound System
3. Device Description:
iVis20/iVis30/i3/ Q1/Q2/Q3/Q5 ultrasound system İs an integrated The CHISON preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
{1}------------------------------------------------
The CHISON ultrasound system can be configured as a roll-around model on wheels (iVis20/iVis30/i3/ Q1/Q2/Q3/Q5). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems which have been available in the market for years.
This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes.
The CHISON iVis Models and Q Models and i3. have been designed to meet the following product safety standards: NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1.
4. Indications for Use:
The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parotid, submaxillary gland, testes and breast.). Peripheral Vascular, Transvaginal, Transrectal, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology.
5. Comparison to Predicate Device:
The CHISON iVis Models and Q Models and i3 are of comparable type and substantially equivalent to the current Voluson E8 (K101236). All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body, and have the same intended uses and basic operating modes as the predicate device. All systems allow for specialized measurements of structures and flow, and calculations.
6. Conclusion:
The CHISON iVis Models and Q Models and i3 are substantially equivalent in safety and effectiveness to the predicate systems. The systems are intended for diagnostic ultrasound imaging and fluid flow analysis. The systems have the same gray-scale and Doppler capabilities. The systems have acoustic output levels below the applicable FDA limits. The systems are designed to applicable electrical and physical safety standards.
End of 510(k) Summary.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with its wings spread and its head turned to the left.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
FEB - 3 2012
Chison Medical Imaging Co., Ltd. % Mr. Bob Leiker Owner, U.S. Agent Leiker Regulatory & Quality Consulting 7263 Cronin Circle DUBLIN CA 94568
Re: K113359
Trade/Device Name: CHISON iVis Series & Q Series, i3 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: November 4, 2011 Received: November 14, 2011
Dear Mr. Leiker:
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 CHISON iVis Series & Q Series, i3 Diagnostic Ultrasound Systems, as described in your premarket notification:
Transducer Model Number
D3C60L, 2.5-4.0MHz Convex Array D4C40L, 3.0-6.4MHz Convex Array D6C12L, 5.3-10MHz Micro-convex Array D7C10L, 5.33-10MHz Micro-convex Array D7L40L, 5.3-10MHz Linear Array
{3}------------------------------------------------
D7L60L, 5.33-10MHz Linear Array V4C40L, 3.0-5.3 MHz Convex Array D6C15L, 4.0-8.0MHz Convex Array D7L30L, 5.33-10MHz Linear Array D5C20L, 4.0-8.0MHz Convex Array D3C20L, 2.5-4.0MHz convex Array
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 895. 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 iaboning (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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely Yours,
Mary Scott
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
Diagnostic Ultrasound Indications For Use
1.3 Indications for Use
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.), Peripheral Vascular, Transvaginal, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology.
Mary S. Pastel
(Division Sign-Off Division of Radiological Device Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113359
Over-The-Counter Use Prescription Use Y AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) of Device Evaluation (ODE)
Section 1.3
Indications For Use
Page 1 of 13
{5}------------------------------------------------
Diagnostic Ultrasound Indications For Use
CHISON iVis Series & Q Series ,i3 Diagnostic Ultrasound Systems System: Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWDNote 3 | ColorDoppler | PowerDoppler | Combined | Other* |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | N | |||||||
| Abdominal | N | N | N | N | N | Note 1 | |||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | Note 1 | |||
| Small Organ[1] (Specify) | N | N | N | N | N | Note 1 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | N | N | N | N | N | Note 1 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | Note 1 | |||
| Musculo-skeletal (Superficial) | N | N | N | N | N | Note 1 | |||
| Intravascular | |||||||||
| Other(Urology) | N | N | N | N | N | Note 1 | |||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | |||
| Cardiac | Cardiac Adult | N | N | N | N | N | Note 1 | ||
| Cardiac Pediatric | N | N | N | N | N | Note 1 | |||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | ||
| Other (Specify) |
E = added under this appendix P = previously cleared by FDA; N = new indication; Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Other*: 3-D , 4-D Imaging, [1] Small Organ: Thyroid, parotid,submaxillary gland, testes and breast Note 3: CWD Mode is not available on all transducers.
| Prescription Use | √ | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off) |
|---|
| Division of Radiological Devices |
| Office of In Vitro Diagnostic Device Evaluation and Safety |
| 510K | K113359 |
|---|---|
| ------ | --------- |
| Section 1.3 | Indications For Use | Page 2 of 13 |
|---|---|---|
| ------------- | --------------------- | -------------- |
Section 1.3
{6}------------------------------------------------
System: CHISON iVis Series & Q Series i3 Diagnostic Ultrasound Systems Transducer: D3C60L, 2.5-4.0MHz Convex Array
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWDNote 3 | ColorDoppler | PowerDoppler | Combined | Other |
| (Track 1 Only) | (Tracks 1 & 3) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | N | N | N | N | N | Note 1 | ||
| Abdominal | N | N | N | N | N | Note 1 | |||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ1 (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other(Urology) | N | N | N | N | N | Note 1 | |||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | |||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel Peripheral vessel | |||||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
E = added under this appendix P = previously cleared by FDA; N = new indication; Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Note 3: CWD Mode is not available on all transducers.
Prescription Use V
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) CONTINUE ON ANOTHER PAGE IF NEEDED) (PLEASE DO NOT WRITE BEL
Mary Patil
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113359
Section 1,3
{7}------------------------------------------------
iVis Series & Q Series, i3 Diagnostic Ultrasound Systems
Chison Medical Imaging Co., Ltd.
CHISON iVis Series & Q Series ,i3 Diagnostic Ultrasound Systems System: D4C40L,3.0-6.4MHz Convex Array Transducer:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWDNote 3 | ColorDoppler | PowerDoppler | Combined | Other* | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging &Other | Fetal | N | N | N | N | N | Note 1 | |||
| Abdominal | N | N | N | N | N | Note 1 | ||||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (1) (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other(Urology) | N | N | N | N | N | Note 1 | ||||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | ||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (Specify) | ||||||||||
| Peripheral Vessel | Peripheral vessel | |||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Note 1: B+M, B+PWD, B+Color Doppler, pr Note 3: CWD Mode is not available on all transducers.
Prescription Use - _ V __ V
AND/OR
Over-The-Counter Use
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
|---|---|
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |
| DRH, Office of Device Evaluation (ODE) | |
| MD-ubbils Unislar | |
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
Section 1.3
510K
259
{8}------------------------------------------------
CHISON iVis Series & Q Series ;i3 Diagnostic Ultrasound Systems System: D6C12L, 5.3-10MHz Micro-convex Array Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWDNote 3 | ColorDoppler | PowerDoppler | Combined | Other* | ||
| General(Track 1 Only) | Specific(Tracks 1 & 3) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | ||||||||
| Other | Abdominal | ||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ[1] (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans- rectal | |||||||||
| Trans- vaginal | N | N | N | N | N | Note 1 | |||
| Trans- urethral | |||||||||
| Trans- esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other(Urology) | N | N | N | N | N | Note 1 | |||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | |||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
P = previously cleared by FDA; E = added under this appendix N = new indication; Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Note 3: CWD Mode is not available on all transducers.
Prescription Use V
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
PLEASE DO NOT WRITE BELOW THIS LINE-CONT
(21 CFR 801 Subpart C)
TINUE ON ANOTHER PAGE IF NEEDED)
Mary S Patil
(Division Sign-Off)
Office of In
510 For Use
Section 1.3
Page 5 of 13
{9}------------------------------------------------
CHISON iVis Series & Q Series ,i3 Diagnostic Ultrasound Systems System: D7C10L, 5.33-10MHz Micro-convex Array Transducer:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWDNote 3 | ColorDoppler | PowerDoppler | Combined | Other* | ||
| General(Track 1 Only) | Specific(Tracks 1 & 3) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ[1] (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans- rectal | |||||||||
| Trans- vaginal | N | N | N | N | N | Note 1 | |||
| Trans-urethral | |||||||||
| Trans- esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other(Urology) | N | N | N | N | N | Note 1 | |||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | |||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
P = previously cleared by FDA; . E = added under this appendix N = new indication; Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Note 3: CWD Mode is not available on all transducers.
Prescription Use _ V AND/OR
Over-The-Counter Use
| (Part 21 CFR 801 Subpart D) | |
|---|---|
| (PLEASE DO NOT WRITE BELOW TH |
(21 CFR 801 Subpart C)
ONTINUE ON ANOTHER PAGE IF NEEDED)
Mary Patel
(Division Sign-Off)
Division of Radiological Davices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113359
Section 1.3
{10}------------------------------------------------
CHISON iVis Series & Q Series ,i3 Diagnostic Ultrasound Systems System: D7L40L, 5.3-10MHz Linear Array Transducer:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWDNote 3 | ColorDoppler | PowerDoppler | Combined | Other* | ||
| General(Track 1 Only) | Specific(Tracks 1 & 3) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | Note 1 | |||
| Small Organ1 (Specify) | N | N | N | N | N | Note 1 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans- rectal | |||||||||
| Trans- vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans- esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | Note 1 | |||
| Musculo-skeletal (Superficial) | N | N | N | N | N | Note 1 | |||
| Intravascular | |||||||||
| Other(Urology) | |||||||||
| Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | ||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
E = added under this appendix P = previously cleared by FDA; N = new indication; Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Additional Comments: [1] Small Organ: Thyroid, parotid, submaxillary gland, testes and breast Note 3: CWD Mode is not available on all transducers.
Prescription Use _ V
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Mary S. Postill
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
cations For Use Section 1.3 510K
Page 7 of 13
{11}------------------------------------------------
iVis Series & Q Series, i3 Diagnostic Ultrasound Systems
CHISON iVis Series & Q Series ,i3 Diagnostic Ultrasound Systems System: D7L60L. 5.33-10MHz Linear Array Transducer:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWDNote 3 | ColorDoppler | PowerDoppler | Combined | Other* | ||
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWDNote 3 | ColorDoppler | PowerDoppler | Combined | Other* |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | Fetal | ||||||||
| Other | Abdominal | ||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | Note 1 | |||
| Small Organ11 (Specify) | N | N | N | N | N | Note 1 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans- rectal | |||||||||
| Trans- vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans- esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | Note 1 | |||
| Musculo-skeletal (Superficial) | N | N | N | N | N | Note 1 | |||
| Intravascular | |||||||||
| Other(Urology) | |||||||||
| Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | ||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
E = added under this appendix N = new indication; Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Additional Comments: [1] Thyroid, parathyroid, parotid,submaxillary gland, testes and breast Note 3: CWD Mode is not available on all transducers.
Prescription Use _ V
AND/OR
Over-The-Counter Use
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
|---|---|
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
Mary S. Podell
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Section 1.3 510K K113
{12}------------------------------------------------
CHISON iVis Series & Q Series ,i3 Diagnostic Ultrasound Systems System: V4C40L, 3.0-5.3 MHz Convex Array Transducer:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWDNote 3 | ColorDoppler | PowerDoppler | Combined | Other* |
| (Track 1 Only) | (Tracks 1 & 3) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | Fetal | N | N | ||||||
| Other | Abdominal | N | N | N | N | N | N | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ[1] (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other(Urology) | N | N | N | N | N | N | |||
| Other (Ob/GYN) | N | N | N | N | N | N | |||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
P = previously cleared by FDA; E = added under this appendix N = new indication; Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler+PWD, B+Power Doppler+PWD, B+Power Doppler+PWD Other*: 3-D,4-D Imaging
Note 3: CWD Mode is not available on all transducers.
Prescription Use _ V
AND/OR
Over-The-Counter Use
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
|---|---|
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |
| Consurrence of CDRH, Office of Device Evaluation (ODE) |
Mary Spatil
(Division Sign-Off)
A Radiolouk Division Office of In Vitro Diagnost
Section 1.3
r Use 510K
Page 9 of 13
{13}------------------------------------------------
CHISON iVis Series & Q Series ,i3 Diagnostic Ultrasound Systems System: D6C15L, 4.0-8.0MHz Convex Array Transducer:
| Clinical Application | Mode of Operation | Other* | |||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWDNote 3 | ColorDoppler | PowerDoppler | Combined | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | N | N | N | N | N | Note 1 | ||
| Abdominal | N | N | N | N | N | Note 1 | |||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ[1] (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other(Urology) | N | N | N | N | N | Note 1 | |||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | |||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
E = added under this appendix N = new indication; P = previously cleared by FDA; Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Note 3: CWD Mode is not available on all transducers.
Prescription Use _ V
AND/OR
Over-The-Counter Use
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------- | ------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
соёл оffice of Device Fugluation (ODF)
Mary S Patil
(Division Sign-Off)
of Radiological Devices Division Division of In Vitro Division of Hadlological Softety
K113359
510K
Indications For Use
Page 10 of 13
Section 1.3
{14}------------------------------------------------
CHISON iVis Series & Q Series ,i3 Diagnostic Ultrasound Systems System: D7L30L, 5.33-10MHz Linear Array Transducer:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWDNote 3 | ColorDoppler | PowerDoppler | Combined | Other* | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging & | Fetal | |||||||||
| Other | Abdominal | |||||||||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | N | Note 1 | |||
| Musculo-skeletal (Superficial) | N | N | N | N | N | N | Note 1 | |||
| Intravascular | ||||||||||
| Other(Urology) | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (Specify) | ||||||||||
| Peripheral Vessel | Peripheral vessel | |||||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Note 3: CWD Mode is not available on all transducers.
Prescription Use
AND/OR
Over-The-Counter Use
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------- | ------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
10
Mary Postel
(Division Sign-Off)
n of Redicingio S FVA Latior Office of In Vitro Diagn
510K. K113359
{15}------------------------------------------------
CHISON iVis Series & Q Series ,i3 Diagnostic Ultrasound Systems System: Transducer: D5C20L, 4.0-8.0MHz convex Array
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWDNote 3 | ColorDoppler | PowerDoppler | Combined | Other* | ||
| General(Track 1 Only) | Specific(Tracks 1 & 3) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | ||||||||
| Other | Abdominal | N | N | N | N | N | Note 1 | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | Note 1 | |||
| Small Organ[1] (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other(Urology) | N | N | N | N | N | Note 1 | |||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | |||
| Cardiac | Cardiac Adult | N | N | N | N | N | Note 1 | ||
| Cardiac Pediatric | N | N | N | N | N | Note 1 | |||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
P = previously cleared by FDA; E = added under this appendix N = new indication; Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler+PWD, B+Power Doppler+PWD Note 3: CWD Mode is not available on all transducers. Additional Comments:
Prescription Use √
AND/OR
Over-The-Counter Use
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------- | ------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary Postill
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Section 1.3
Office of In Vitro
K115559
510K Indications for Use
Page 12 of 13
{16}------------------------------------------------
CHISON iVis Series & Q Series .i3 Diagnostic Ultrasound Systems System: Transducer: D3C20L, 2.5-4.0MHz convex Array
Mode of Operation Clinical Application PWD CWD Color Power Other* B M General Specific Combined Doppler (Tracks 1 & 3) Note 3 Doppler (Track 1 Only) Ophthalmic Ophthalmic Fetal Imaging & Fetal Other Abdominal Intra-operative (Specify) Intra-operative (Neuro) Laparoscopic Pediatric Small Organ(1) (Specify) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Intravascular Other(Urology) Other (Ob/GYN) N N Note 1 న N N Cardiac Adult Cardiac Note 1 N N N N N Cardiac Pediatric Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-cardiac Other (Specify) Peripheral Vessel |Peripheral vessel Other (Specify)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
E = added under this appendix P = previously cleared by FDA; N = new indication: Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Note 3: CWD Mode is not available on all transducers. Additional Comments:
Prescription Use _ V
510K
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Maw & Pastel
Ision of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sefety Indications For Use Section 1.3
Page 13 of 13
§ 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.