(81 days)
Not Found
No
The document describes a standard ultrasound system with various imaging modes and post-processing capabilities, but there is no mention of AI, ML, or related concepts.
No
The device is described as a "diagnostic ultrasound imaging system" and its "basic function is to acquire ultrasound echo data and display the image," indicating it is used for diagnosis, not therapy.
Yes
The Device Description explicitly states: "This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system."
No
The device description explicitly states it is an "integrated preprogrammed color doppler ultrasound imaging system" and can be configured as a "roll-around model on wheels," indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body). The description clearly states this device is an "ultrasonic imaging instrument" that acquires "ultrasound echo data" to display images of "anatomic structures and fluid flow within the body." This is an in vivo (within the body) imaging technique.
- The intended use and device description focus on imaging internal structures of the body. There is no mention of analyzing biological samples.
Therefore, this device falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 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.
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 | CWD | |||||
| Note 3 | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | 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 | CWD | ||||
| Note 3 | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | 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 | CWD | ||||||
| Note 3 | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | 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 | CWD | ||||||
| Note 3 | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | 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 | CWD | ||||||
| Note 3 | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | 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 | CWD | ||||||
| Note 3 | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | 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 | CWD | ||||||
| Note 3 | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | Other* | |||||||
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | |||||
| Note 3 | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | 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 | CWD | ||||
| Note 3 | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | 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 | CWD | |||||
| Note 3 | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | 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 | CWD | ||||||
| Note 3 | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | 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 | CWD | ||||||
| Note 3 | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | 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