(323 days)
Not Found
No
The summary describes standard ultrasound imaging techniques and digital signal processing methods (autocorrelation, FFT) without mentioning AI or ML algorithms.
No
The device is described as a "Diagnostic Doppler Ultrasound System" intended for "evaluation" and "diagnostic imaging applications," which are all related to diagnosis rather than therapy.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is a "Diagnostic Doppler Ultrasound System" and is intended for "clinical diagnostic imaging applications."
No
The device description explicitly states it is a "compact and portable diagnostic ultrasound device" with "integrated preprogrammed color ultrasound imaging system," indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Function: The OPUS 5100 Diagnostic Doppler Ultrasound System is an imaging device that uses ultrasound waves to create images of internal structures within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "evaluation of Fetal, Abdomen; Pediatric; Small Organ... and Peripheral Vascular," which are all in-vivo (within the living body) applications.
The device description and intended use are consistent with a diagnostic imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
OPUS 5100 Diagnostic Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdomen; Pediatric; Small Organ(breast, thyroid, tests); Cephalic (adult and neonatal); Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional and Superficial); Ob/GYN; Urology; Cardiac (adult and pediatric) and Peripheral Vascular.
Product codes
IYN, IYO, ITX
Device Description
OPUS 5100 Diagnostic Doppler Ultrasound System is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
The major features of OPUS 5100 Diagnostic Doppler Ultrasound System: 128 Channel all digital beam former; progressive dynamic receive focusing; wide band all digital demodulation; native frequency digital scan converter; hand carried for portable use; remote access image management through LAN port: USB 2.0 drive for image storage and retrieving; Supports 2D B-mode (including Tissue Harmonic image, M-mode, TDI, Color Flow Doppler, Power Doppler, Pulse wave Doppler and Continuous Wave Doppler, or a combination of these modes, 3D/4D.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic pulsed doppler imaging, Ultrasonic pulsed echo imaging
Anatomical Site
Fetal, Abdomen, Pediatric, Small Organ(breast, thyroid, tests), Cephalic (adult and neonatal), Trans-rectal, Trans-vaginal, Musculo-skeletal(Conventional and Superficial), Ob/GYN, Urology, Cardiac (adult and pediatric), Peripheral Vascular.
Indicated Patient Age Range
Adult, pediatric, neonatal, fetal
Intended User / Care Setting
qualified physician / Hospitals, clinics usage.
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)
Laboratory testing was conducted to verify that the OPUS 5100 Diagnostic Doppler Ultrasound System was substantially equivalent to the Predicate Device.
- IEC 60601-1: 2005 Medical Electrical Equipment Part 1: General Requirement for Safety.
- IEC 60601-1-2: 2007 Medical Electrical Equipment Part1-2: General Requirement for Safety - Collateral Standard: Electromagnetic Compatibility - Requirement and Tests.
- IEC 60601-2-37: 2008 Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
- NEMA UD3: 2004 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.
- NEMA UD 2: 2004. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2015
Chang Gung Medical Technology Co., Ltd. % Mr. Bob Leiker Owner Leiker Regulatory & Quality Consulting 4157 North Del Rey Avenue CLOVIS CA 93619
Re: K142982
Trade/Device Name: OPUS 5100 Diagnostic Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 6, 2015 Received: August 10, 2015
Dear Mr. Leiker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Oals
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
142982
Device Name
OPUS 5100 Diagnostic Doppler Ultrasound System
Indications for Use (Describe)
OPUS 5100 Diagnostic Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdomen; Pediatric; Small Organ(breast, thyroid, tests); Cephalic (adult and neonatal); Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional and Superficial); Ob/GYN; Urology; Cardiac (adult and pediatric) and Peripheral Vascular.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
PSC Publishing Services (301) 443-6740
3
Section 1.3 Indications for Use
K142982 510(k) Number:
Device Name: OPUS 5100 Diagnostic Doppler Ultrasound System
Indications for Use:
OPUS 5100 Diagnostic Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdomen; Pediatric; Small Organ(breast, thyroid, tests); Cephalic (adult and neonatal); Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional and Superficial); Ob/GYN; Urology; Cardiac (adult and pediatric) and Peripheral Vascular.
The following transducers are intended for use with OPUS 5100 Diagnostic Doppler Ultrasound System.
| Transducer model Number | ||
|---|---|---|
| LA75 Linear Array | CLA35 Curve Linear Array | MCLA65 Micro-Curved Linear array |
| LA75T Linear Array | CLA35R5 Curve Linear Array | PA25 Phase Array |
| LA75C Linear Array | CLA35C Curve Linear Array | PA25S Phase Array |
| LA75S Linear Array | CLA35T Curve Linear Array | PA25E8 Phase Array |
| LA80N Linear Array | CLA35S Curve Linear Array | PA50 Phase Array |
| LA85N Linear Array | TV65 Transvaginal Micro-Curved | |
| Linear array | M3D45 4D Curved Array | |
| LA10N Linear Array | TV65S Transvaginal Micro-Curved | |
| Linear array | CGTE50 Multi-Plane Phased Array |
Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
4
Chang Gunq Medical Technology Co., Ltd. System: OPUS 5100 Diagnostic Doppler Ultrasound System 510(k) Submission
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | ||||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Harmonic | |||||||||
| Imaging | Other | |||||||||
| General | ||||||||||
| (Track 1 Only) | Specific | |||||||||
| (Tracks 1 & 3) | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | N | N | N | N | N | N | Note 1 | N | Note 3, 4 |
| Abdominal | N | N | N | N | N | N | Note 1 | N | Note 3, 4 | |
| Intra-operative (Specify) | N | |||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Small Organ1 (Specify) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | |
| Adult Cephalic | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | |
| Trans-rectal | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Trans-vaginal | N | N | N | N | N | Note 1 | N | Note 3 | ||
| Trans-urethral | ||||||||||
| Trans-esoph. (non- | ||||||||||
| Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Musculo-skeletal | ||||||||||
| (Superficial) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Other (Urology) | N | N | N | N | N | Note 1 | N | Note 3, 4 | ||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | N | Note 3, 4 | ||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N | Note 2, 3 |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | |
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | N | Note 3 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
5
Diagnostic Ultrasound Indications For Use
Transducer: LA75 Linear Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | |||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes | Harmonic | ||||||||||
| Imaging | 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) | N | N | N | N | N | N | Note 1 | N | Note 3 | ||
| 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 | N | Note 3 | ||
| Musculo-skeletal | |||||||||||
| (Superficial) | N | N | N | N | N | N | Note 1 | N | Note 3 | ||
| Other (Urology) | |||||||||||
| Other (Ob/GYN) | |||||||||||
| Cardiac | Cardiac Adult | ||||||||||
| Cardiac Pediatric | |||||||||||
| Peripheral | |||||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | N | Note 3 |
N = new indication; P = previously cleared by FDA;
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
6
LA75T Linear Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | |||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes | Harmonic | ||||||||||
| Imaging | 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) | N | N | N | N | N | N | Note 1 | N | Note 3 | ||
| 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 | N | Note 3 | ||
| Musculo-skeletal | |||||||||||
| (Superficial) | N | N | N | N | N | N | Note 1 | N | Note 3 | ||
| Other (Urology) | |||||||||||
| Other (Ob/GYN) | |||||||||||
| Cardiac | Cardiac Adult | ||||||||||
| Cardiac Pediatric | |||||||||||
| Peripheral | |||||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| N = new indication; | P = previously cleared by FDA; | E = added under this appendix |
N = new indication; P = previously cleared by FDA;
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
7
LA75C Linear Array Transducer: Diagnostic Ultrasound Transducer
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 | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes | Harmonic | ||||||||||
| Imaging | Other | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal Imaging | |||||||||||
| & Other | Fetal | Fetal | |||||||||
| Abdominal | |||||||||||
| Intra-operative (Specify) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ1 (Specify) | N | N | N | N | N | N | Note 1 | N | Note 3 | ||
| 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 | N | Note 3 | ||
| Musculo-skeletal | |||||||||||
| (Superficial) | N | N | N | N | N | N | Note 1 | N | Note 3 | ||
| Other (Urology) | |||||||||||
| Other (Ob/GYN) | |||||||||||
| Cardiac | Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||||
| Peripheral | |||||||||||
| Vessel | Peripheral | ||||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| N = new indication; |
N = new indication; P = previously cleared by FDA;
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
8
LA75S Linear Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | ||||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Harmonic | |||||||||
| Imaging | Other | |||||||||
| General | ||||||||||
| (Track 1 Only) | Specific | |||||||||
| (Tracks 1 & 3) | B | M | PW | |||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Harmonic | |||||||||
| Imaging | Other | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ1 (Specify) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| 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 | N | Note 3 | |
| Musculo-skeletal | ||||||||||
| (Superficial) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Other (Urology) | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | N | Note 3 |
| N = new indication; | E = added under this appendix |
N = new indication; P = previously cleared by FDA;
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
9
LA80N Linear Array Transducer: Diagnostic Ultrasound Transducer
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 | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes | Harmonic | |||||||||||
| Imaging | Other | |||||||||||
| Ophthalmic | Ophthalmic | |||||||||||
| Fetal Imaging | ||||||||||||
| & Other | Fetal | |||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ1 (Specify) | N | N | N | N | N | N | Note 1 | N | Note 3 | |||
| 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 | N | Note 3 | |||
| Musculo-skeletal | ||||||||||||
| (Superficial) | N | N | N | N | N | N | Note 1 | N | Note 3 | |||
| Other (Urology) | ||||||||||||
| Other (Ob/GYN) | ||||||||||||
| Cardiac | Cardiac Adult | |||||||||||
| Cardiac Pediatric | ||||||||||||
| Peripheral | ||||||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | N | Note 3 | ||
| N = new indication; | P = previously cleared by FDA; | |||||||||||
| E = added under this appendix |
N = new indication; P = previously cleared by FDA;
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
10
LA85N Linear Array Transducer: Diagnostic Ultrasound Transducer
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 | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes | Harmonic | |||||||||||
| Imaging | Other | |||||||||||
| Ophthalmic | Ophthalmic | |||||||||||
| Fetal Imaging | ||||||||||||
| & Other | Fetal | |||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ1 (Specify) | N | N | N | N | N | N | Note 1 | N | Note 3 | |||
| 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 | N | Note 3 | |||
| Musculo-skeletal | ||||||||||||
| (Superficial) | N | N | N | N | N | N | Note 1 | N | Note 3 | |||
| Other (Urology) | ||||||||||||
| Other (Ob/GYN) | ||||||||||||
| Cardiac | Cardiac Adult | |||||||||||
| Cardiac Pediatric | ||||||||||||
| Peripheral | ||||||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | N | Note 3 | ||
| N = new indication; | P = previously cleared by FDA; | |||||||||||
| E = added under this appendix |
N = new indication; P = previously cleared by FDA;
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
11
LA10N Linear Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | |||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes | Harmonic | ||||||||||
| Imaging | 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) | N | N | N | N | N | N | Note 1 | N | Note 3 | ||
| 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 | N | Note 3 | ||
| Musculo-skeletal | |||||||||||
| (Superficial) | N | N | N | N | N | N | Note 1 | N | Note 3 | ||
| Other (Urology) | |||||||||||
| Other (Ob/GYN) | |||||||||||
| Cardiac | Cardiac Adult | ||||||||||
| Cardiac Pediatric | |||||||||||
| Peripheral | |||||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| N = new indication; | P = previously cleared by FDA; | ||||||||||
| E = added under this appendix |
N = new indication; P = previously cleared by FDA;
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
12
CLA35 Curved Linear Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | |||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes | Harmonic | ||||||||||
| Imaging | Other | ||||||||||
| General | |||||||||||
| (Track 1 Only) | Specific | ||||||||||
| (Tracks 1 & 3) | |||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal Imaging | |||||||||||
| & Other | Fetal | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| & Other | Abdominal | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| 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) | |||||||||||
| Other (Urology) | N | N | N | N | N | N | Note 1 | N | Note 3 | ||
| Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | N | Note 3 | ||
| Cardiac | Cardiac Adult | ||||||||||
| Cardiac Pediatric | |||||||||||
| Peripheral | |||||||||||
| Vessel | Peripheral vessel |
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
13
CLA35R5 Curved Linear Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | ||||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Harmonic | |||||||||
| Imaging | Other | |||||||||
| General | ||||||||||
| (Track 1 Only) | Specific | |||||||||
| (Tracks 1 & 3) | B | M | PW | CW | Color | Power | Combined | |||
| Modes | Harmonic | |||||||||
| Imaging | Other | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | N | N | N | N | N | N | Note 1 | N | Note 3 |
| & Other | Abdominal | N | N | N | N | N | N | Note 1 | N | Note 3 |
| 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) | ||||||||||
| Other (Urology) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel |
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
14
CLA35C Curved Linear Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | ||||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Harmonic | |||||||||
| Imaging | Other | |||||||||
| General | ||||||||||
| (Track 1 Only) | Specific | |||||||||
| (Tracks 1 & 3) | B | M | PW | CW | Color | Power | Combined | |||
| Modes | Harmonic | |||||||||
| Imaging | Other | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | N | N | N | N | N | N | Note 1 | N | Note 3 |
| & Other | Abdominal | N | N | N | N | N | N | Note 1 | N | Note 3 |
| 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) | ||||||||||
| Other (Urology) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel |
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
15
CLA35T Curved Linear Array Transducer: Diagnostic Ultrasound Transducer
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 | PW | |||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Harmonic | |||||||||
| Imaging | Other | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | N | N | N | N | N | N | Note 1 | N | Note 3 |
| Abdominal | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| 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) | ||||||||||
| Other (Urology) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel |
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
16
CLA35S Curved Linear Array Transducer: Diagnostic Ultrasound Transducer
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 | PW | |||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Harmonic | |||||||||
| Imaging | Other | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | N | N | N | N | N | N | Note 1 | N | Note 3 |
| Abdominal | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| 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) | ||||||||||
| Other (Urology) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel |
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
17
TV65 Transvaqinal Micro-Curved Linear Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | ||||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Harmonic | |||||||||
| Imaging | 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 | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Trans-vaginal | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Trans-urethral | ||||||||||
| Trans-esoph. (non- | ||||||||||
| Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Other (Urology) | ||||||||||
| Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | |||||||||
| N = new indication; P = previously cleared by FDA; E = added under this appendix |
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
X AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
18
TV65S Transvaginal Micro-Curved Linear Array Transducer: Diagnostic Ultrasound Transducer
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 | PW | |||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Harmonic | |||||||||
| Imaging | Other | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ1 (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Trans-vaginal | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Trans-urethral | ||||||||||
| Trans-esoph. (non- | ||||||||||
| Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Other (Urology) | ||||||||||
| Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | |||||||||
| N = new indication; | P = previously cleared by FDA; | E = added under this appendix |
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
X AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
19
MCLA65 Micro-Curved Linear Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | ||||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Harmonic | |||||||||
| Imaging | 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) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non- | ||||||||||
| Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Other (Urology) | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N | Note 2, 3 |
| Cardiac Pediatric | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | |||||||||
| N = new indication; | ||||||||||
| [1]: breast, thyroid, testes | P = previously cleared by FDA; | E = added under this appendix |
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
X AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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20
PA25 Phased Array Transducer: Diagnostic Ultrasound Transducer
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 | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes | Harmonic | ||||||||||
| Imaging | Other | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal Imaging | |||||||||||
| & Other | Fetal | ||||||||||
| Abdominal | |||||||||||
| Intra-operative (Specify) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ1 (Specify) | |||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | ||
| Adult Cephalic | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | ||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non- | |||||||||||
| Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Superficial) | |||||||||||
| Other (Urology) | |||||||||||
| Other (Ob/GYN) | |||||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | ||
| Peripheral | |||||||||||
| Vessel | Peripheral vessel | ||||||||||
| N = new indication; | P = previously cleared by FDA; E = added under this appendix |
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
21
PA25S Phased Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | |||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes | Harmonic | ||||||||||
| Imaging | 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 | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | ||
| Adult Cephalic | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | ||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non- | |||||||||||
| Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Superficial) | |||||||||||
| Other (Urology) | |||||||||||
| Other (Ob/GYN) | |||||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | ||
| Peripheral | |||||||||||
| Vessel | Peripheral vessel | ||||||||||
| N = new indication; | P = previously cleared by FDA; | E = added under this appendix |
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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22
PA25E8 Phased Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | |||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes | Harmonic | ||||||||||
| Imaging | 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 Organ1 (Specify) | |||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | ||
| Adult Cephalic | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | ||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non- | |||||||||||
| Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Superficial) | |||||||||||
| Other (Urology) | |||||||||||
| Other (Ob/GYN) | |||||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | ||
| Peripheral | |||||||||||
| Vessel | Peripheral vessel | ||||||||||
| N = new indication; | P = previously cleared by FDA; | E = added under this appendix |
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
23
PA50 Phased Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | ||||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Harmonic | |||||||||
| Imaging | 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 | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | |
| Adult Cephalic | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | |
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non- | ||||||||||
| Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Other (Urology) | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N | Note 2, 3 |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | N | Note 2, 3 | |
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | |||||||||
| N = new indication; P = previously cleared by FDA; E = added under this appendix |
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
24
M3D45 4D Curved Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | ||||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Harmonic | |||||||||
| Imaging | Other | |||||||||
| General | ||||||||||
| (Track 1 Only) | Specific | |||||||||
| (Tracks 1 & 3) | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | N | N | N | N | N | N | Note 1 | N | Note 3, 4 |
| Abdominal | N | N | N | N | N | N | Note 1 | N | Note 3, 4 | |
| 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) | ||||||||||
| Other (Urology) | N | N | N | N | N | N | Note 1 | N | Note 3, 4 | |
| Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | N | Note 3, 4 | |
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel |
[1]: breast, thyroid, testes
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
25
CGTE50 Multi-Plane Phased Array Transducer: Diagnostic Ultrasound Transducer
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 | PW | |||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Harmonic | |||||||||
| Imaging | Other | |||||||||
| 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 | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non- | ||||||||||
| Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Other (Urology) | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N | Note 2, 3 |
| Cardiac Pediatric | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | |||||||||
| N = new indication; P = previously cleared by FDA; E = added under this appendix | ||||||||||
| [1]: breast, thyroid, testes |
Note 1: Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; M/Color M; B/Color Doppler/PWD and B/Power Doppler/PWD.
Note 2: TDI Note 3: 3D Note 4: 4D
X AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
26
IDA CDRH DMC
K142982/A001
APR 2 8 2015
Chang Gung Medical Technology Co., Ltd. OPUS 5100 Diagnostic Doppler Ultrasound System 510(k) Submission
Section 04 - 510(k) Summary
Received
-
Date Prepared July 07 2014.
-
Submitter
| Company Name: | Chang Gung Medical Technology Co., Ltd. |
|---|---|
| Head Office Address: | 11F., No. 201-4, Dunhua North Rd., Songshan Dist., Taipei City |
| 10508, Taiwan R.O.C. | |
| Manufacturer Address: | 2F., No. 118, Nanlin Rd., Taishan Dist., New Taipei City 24352, |
| Taiwan R.O.C. |
Establishment Registration Number: 3005706637
| Contact: | Shu Ping Tsao |
|---|---|
| E-mail: | iristsao@cgmh.org.tw |
| Phone: | +886-2-29069595 |
| Fax: | +886-2-29069797 |
Corresponding U.S. Agent
| Contact: | Bob Leiker |
|---|---|
| Leiker Regulatory & Quality Consulting | |
| Address: | 4157 North Del Rey Ave, Clovis, California 93619 |
| Phone: | (925) 719-1946 |
| Fax: | (866) 718-3819 |
| E-mail: | bobleiker@comcast.net |
3. Identification of the Device
| Device Name: | OPUS 5100 Diagnostic Doppler Ultrasound System | ||
|---|---|---|---|
| Common Name: | Diagnostic Ultrasound System and Transducers | ||
| Classification Name: | 21 CRF892.1550 Ultrasonic Pulsed Doppler Imaging System | Product code: IYN | |
| 21 CRF892.1560 Ultrasonic Pulsed Echo Imaging System | Product code: IYO | ||
| 21 CRF892.1570 Diagnostic Ultrasound Transducer | Product code: ITX | ||
| Classification Panel: | Radiology | ||
| Device Classification: | Class II | ||
| Review Category: | Tier II |
4. Identification of the Predicate Device
| Predicate Device Name: | Portable Digital Color Doppler Ultrasound System |
|---|---|
| Model: | S9 |
| Manufacturer: | SonoScape Company Limited |
| 510(k) Number: | K131088 |
510(k) Summary
2
27
5. Device Description
OPUS 5100 Diagnostic Doppler Ultrasound System is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
The major features of OPUS 5100 Diagnostic Doppler Ultrasound System: 128 Channel all digital beam former; progressive dynamic receive focusing; wide band all digital demodulation; native frequency digital scan converter; hand carried for portable use; remote access image management through LAN port: USB 2.0 drive for image storage and retrieving; Supports 2D Bmode (including Tissue Harmonic image, M-mode, TDI, Color Flow Doppler, Power Doppler, Pulse wave Doppler and Continuous Wave Doppler, or a combination of these modes, 3D/4D.
6. Intended Use
OPUS 5100 Diagnostic Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdomen; Pediatric; Small Organ(breast, thyroid, tests); Cephalic (adult and neonatal); Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional and Superficial); Ob/GYN; Urology; Cardiac (adult and pediatric) and Peripheral Vascular.
7. Testing
Laboratory testing was conducted to verify that the OPUS 5100 Diagnostic Doppler Ultrasound System was substantially equivalent to the Predicate Device.
- 8.1 IEC 60601-1: 2005 Medical Electrical Equipment Part 1: General Requirement for Safety.
- 8.2 IEC 60601-1-2: 2007 Medical Electrical Equipment Part1-2: General Requirement for Safety - Collateral Standard: Electromagnetic Compatibility - Requirement and Tests.
- 8.3 IEC 60601-2-37: 2008 Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
- 8.4 NEMA UD3: 2004 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.
- 8.5 NEMA UD 2: 2004. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
- 8.6 ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity.
- 8.7 ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization.
28
8. Clinical Testing
No clinical testing was required.
9. Comparison to the Predicate Device
The difference between the OPUS 5100 Diagnostic Doppler Ultrasound System and the predicate device Portable Digital Color Doppler Ultrasound System, Model S9 in almost every part are listed in the table below.
| Items | Proposed Device | Predicate Device |
|---|---|---|
| General | ||
| Device Name | OPUS 5100 Diagnostic Doppler | |
| Ultrasound System | Portable Digital Color Doppler | |
| Ultrasound System, Model S9 | ||
| Intended Use | The OPUS 5100 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified | |
| physician for evaluation of Fetal, | ||
| Abdomen; Pediatric; Small | ||
| Organ(breast, thyroid, tests); Cephalic | ||
| (adult and neonatal); Trans-rectal; | ||
| Trans-vaginal; Musculo- | ||
| skeletal(Conventional and | ||
| Superficial); Ob/GYN; Urology; | ||
| Cardiac (adult and pediatric) and | ||
| Peripheral Vascular. | The SonoScape S9 device is a | |
| general-purpose ultrasonic imaging | ||
| instrument intended for use by a | ||
| qualified physician for evaluation of | ||
| Fetal, Abdominal, Pediatric, Small | ||
| Organ (breast, testes, thyroid), | ||
| Cephalic(neonatal and adult), Trans- | ||
| rectal, Trans-vaginal, Peripheral | ||
| Vascular, Musculo-skeletal | ||
| (Conventional and Superficial), | ||
| Cardiac (neonatal and adult), OB/Gyn | ||
| and Urology. | ||
| Classification Name | Ultrasonic Pulsed Doppler Imaging | |
| System | ||
| Ultrasonic Pulsed Echo Imaging | ||
| System | ||
| Diagnostic Ultrasound Transducer | Ultrasonic Pulsed Doppler Imaging | |
| System | ||
| Ultrasonic Pulsed Echo Imaging | ||
| System | ||
| Diagnostic Ultrasound Transducer | ||
| Product Code | 90-IYN/90-IYO/90-ITX | 90-IYN/90-IYO/90-ITX |
| Regulation Number | 892.1550/892.1560/892.1570 | 892.1550/892.1560/892.1570 |
| Panel | Radiology | Radiology |
| Class | II | II |
| Specification | ||
| Transducer Types & | ||
| Connectors | LA75 Linear array | |
| LA75T Linear array | ||
| LA75C Linear array | ||
| LA75S Linear array | ||
| LA80N Linear array | ||
| LA85N Linear array | ||
| LA10N Linear array | L741 Linear array | |
| L742 Linear array | ||
| L752 Linear array | ||
| Items | Proposed Device | Predicate Device |
| CLA35 Curved Array | C344 Curved Array | |
| CLA35R5 Curved Array | C322 Curved Array | |
| CLA35C Curved Array | C353 Curved Array | |
| CLA35T Curved Array | ||
| CLA35S Curved Array | ||
| TV65 Transvaginal Micro-Curved | ||
| Array | 6V1 Micro-Curved Array | |
| TV65S Transvaginal Micro-Curved | ||
| Array | 6V3 Micro-Curved Array | |
| MCLA65 Micro-Curved Array | / | |
| PA25 Phased Array | 2P2 Phased Array | |
| PA25S Phased Array | 3P1 Phased Array | |
| PA25E8 Phased Array | 5P2 Phased Array | |
| PA50 Phased Array | 8P1 Phased Array | |
| 4D Curved Array: M3D45 - 4.5 MHz | VC6-2 Curved Array | |
| CGTE50 Multi-Plane Phased Array | / | |
| Multi-port connector connects 2 | ||
| transducers. | Multi-port connector connects 2 | |
| transducers. | ||
| Based on an embedded Linux | ||
| operating system. | Based on an embedded Linux | |
| operating system. | ||
| Based on 128 channel full digital | ||
| beam former. | Based on 128 channel full digital | |
| beam former. | ||
| Autocorrelation for color processing | ||
| and FFT for pulse and CW Doppler | ||
| processing. | Autocorrelation for color processing | |
| and FFT for pulse and CW Doppler | ||
| processing. | ||
| Design | Supporting Linear, Curve linear and | |
| Phase array probes from 2 to 14 MHz. | Supporting Linear, Curve linear and | |
| Phase array probes from 2 to 15 MHz. | ||
| Cine play back capability and Image | ||
| file archive. | Cine play back capability and Image | |
| file archive. | ||
| Software upgrade with USB flash | ||
| drive. | Software upgrade with USB flash | |
| drive. | ||
| Digital Scan Converter 800x600. | Digital Scan Converter 800x600. | |
| Patient Contact | ||
| Materials | RVT664+ Ultrason S2010 silicon | |
| rubber complies with ISO 10993-5. | RVT664+ Ultrason S2010 silicon | |
| rubber complies with ISO 10993-5. | ||
| Operation Mode | B, M, CFM, CPA, PW, CW, THI, | |
| TDI 3D/4D Mode, Color M Mode and | ||
| combine mode. | B, M, PW, CW, CFM, DPI, TDI, | |
| Tissue Harmonic Image, 3D/4D | ||
| Mode, Color M Mode | ||
| Display Mode | Single and dual 2-D; Display of | |
| Duplex 2 D/M-mode; 2-D/Pulsed | ||
| Doppler and Triplex 2-D/CD/Pulsed | ||
| Doppler image formats; Dual B and | Dual B, Quad Display, B and M, B | |
| and Doppler, B+Color, Dual B(Flow), | ||
| Triplex mode; B, CFM, and PW/CW; | ||
| B, DPI, and PW/CW; B, THI and | ||
| Items | Proposed Device | Predicate Device |
| Color in real time. | Color M, steer M, Dual B and Color | |
| in real time, Compound imaging, | ||
| Panoramic Imaging, Trapezoid | ||
| Imaging. | ||
| Display Monitor | 15" LCD color monitor. | 15" Widescreen LCD monitor. |
| Measurement | Distance; Area; Circumference; | |
| Calipers; Volume; Velocity; HR, PI, | ||
| RI, Cardiac, OB/GYN, Urology, | ||
| Vascular and small part package. | Distance; Area; Circumference: | |
| Calipers: Volume: Velocity; HR, PI. | ||
| RI, Cardiac, OB/GYN, Urology, | ||
| Vascular and small part package. | ||
| Users / Sites | Hospitals, clinics usage. | Hospitals, clinics usage. |
| Acoustic Output | Track 3: MI, TIS, TIC, TIB | |
| Derated Ispta: 720 mW/cm² (max.) | ||
| TIS/TIB/TIC: 0.2 ~ 4.0 (Range) | ||
| Mechanical Index: 1.9 (max.) | ||
| Derated Isppa: 190 W/cm² (max.) | Track 3: MI, TIS, TIC, TIB | |
| Derated Ispta: 720 mW/cm² (max.) | ||
| TIS/TIB/TIC: 6.0 (max.) Mechanical | ||
| Index: 1.9 (max.) | ||
| Derated Isppa: 190 W/cm² (max.) | ||
| Labeling | Operator's Manual, brochure. | Operator's Manual, brochure. |
| Power Requirement | Power requirement: | |
| 100 Volts AC, 1.84 Amps | ||
| 120 Volts AC, 1.56 Amps | ||
| 230 Volts AC, 0.81 Amps | ||
| 250 Volts AC, 0.74 Amps | ||
| Power consumption: 130 watts max. | Power requirement: | |
| Voltage: 110-240 VAC | ||
| Frequency: 50/60 Hz | ||
| Power consumption: 110-240VAC, | ||
| 2.7-1.2A | ||
| Operating Condition | Temperature: 5 °~ 40 °. | |
| Relative humidity: 10~ 80%. | ||
| Air pressure: 700 hPa ~ 1060 hPa. | Temperature: 10 °~ 40 °. | |
| Relative humidity: 30 ~ 75%. | ||
| Air pressure: 700 hPa ~ 1060 hPa. | ||
| Storage Condition | Temperature: -25 °~ 55 °. | |
| Relative humidity: 10 ~ 90%. | ||
| Air pressure: 700 hPa ~ 1060 hPa. | Temperature: -20 ° ~ 55 °. | |
| Relative humidity: 20 ~ 90%. | ||
| Air pressure: 700 hPa ~ 1060 hPa. | ||
| Safety Test Items | ||
| Electronic Safety | IEC 60601-1 | IEC 60601-1 |
| Electromagnetic | ||
| Compatibility | IEC 60601-2 | IEC 60601-2 |
| Performance | IEC 60601-2-37 | IEC 60601-2-37 |
| Biocompatibility | ISO 10993-5 | |
| ISO 10993-10 | ISO 10993-5 | |
| ISO 10993-10 | ||
| Level of Concern of | ||
| Software | Moderate level of concern system | Moderate level of concern system |
Table 1 Substantial Equivalent Comparison Table
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10. Conclusion
There are some differences between the proposed device and predicate device. All the parameters comply with 21CFR1020.33 and related IEC standards, so those differences between proposed device and predicate device do not affect the safety and effectiveness.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, it can be concluded that OPUS 5100 Diagnostic Doppler Ultrasound System is substantially equivalent to the predicate device with regard to safety and effectiveness.