OPUS 5100 Diagnostic Doppler Ultrasound System
Device Facts
| Record ID | K142982 |
|---|---|
| Device Name | OPUS 5100 Diagnostic Doppler Ultrasound System |
| Applicant | Chang Gung Medical Technology Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Sep 3, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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.
Device Story
The OPUS 5100 is a portable, hand-carried diagnostic ultrasound system used in hospitals and clinics by qualified physicians. It utilizes various transducers (linear, curved, phased, and 4D arrays) to acquire ultrasonic signals from the human body. The system features a 128-channel digital beamformer that processes these signals to produce real-time diagnostic images. Supported imaging modes include 2D B-mode, M-mode, Tissue Harmonic Imaging (THI), Color Flow Doppler, Power Doppler, Pulse Wave (PW) Doppler, Continuous Wave (CW) Doppler, Tissue Doppler Imaging (TDI), and 3D/4D imaging. The device provides clinicians with visual and quantitative data (e.g., distance, volume, velocity, HR, PI, RI) to assist in clinical evaluation and decision-making across multiple anatomical regions. Data management is supported via LAN and USB 2.0 for storage and retrieval. The system benefits patients by providing non-invasive, high-resolution diagnostic imaging for a wide range of clinical conditions.
Clinical Evidence
No clinical testing was required. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), performance (IEC 60601-2-37), acoustic output (NEMA UD2/UD3), and biocompatibility (ISO 10993-5/10).
Technological Characteristics
Portable, hand-carried ultrasound system. 128-channel digital beamformer. Transducers: linear, curved, phased, and 4D arrays (2-14 MHz). Patient contact materials: RVT664+ Ultrason S2010 silicon rubber (ISO 10993 compliant). Connectivity: LAN, USB 2.0. Display: 15" LCD. Power: 100-250V AC. Software: Embedded Linux-based, moderate level of concern.
Indications for Use
Indicated for use by qualified physicians for diagnostic ultrasound imaging or fluid flow analysis of fetal, abdominal, pediatric, small organ (breast, thyroid, testes), cephalic (adult/neonatal), trans-rectal, trans-vaginal, musculo-skeletal (conventional/superficial), Ob/GYN, urology, cardiac (adult/pediatric), and peripheral vascular applications.
Regulatory Classification
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.
Predicate Devices
- Portable Digital Color Doppler Ultrasound System, Model S9 (K131088)
Related Devices
- K102989 — OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS · Chang Gung Medical Technology Co., Ltd. Linkou Fac · Dec 9, 2010
- K130119 — PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM · Sonoscape Company Limited · Apr 12, 2013
- K132768 — S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM · Sonoscape Company Limited · Oct 4, 2013
- K180039 — ACUSON P600 Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Feb 1, 2018
- K171579 — M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 18, 2017
Submission Summary (Full Text)
{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<br>Linear array | M3D45 4D Curved Array |
| LA10N Linear Array | TV65S Transvaginal Micro-Curved<br>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<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Other |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>& 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-<br>Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | Note 1 | N | Note 3 |
| | Musculo-skeletal<br>(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<br>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<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Other | |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal Imaging<br>& 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-<br>Card.) | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| | Other (Urology) | | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| Peripheral<br>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<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Other | |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal Imaging<br>& 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-<br>Card.) | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| | Other (Urology) | | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| Peripheral<br>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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Other |
| | Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>& 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-<br>Card.) | | | | | | | | | |
| | | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | Note 1 | N | Note 3 |
| | | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | Note 1 | N | Note 3 |
| | | Other (Urology) | | | | | | | | | |
| | | Other (Ob/GYN) | | | | | | | | | |
| Cardiac | Cardiac | Cardiac Adult | | | | | | | | | |
| | | Cardiac Pediatric | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral<br>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<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Other |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Other |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>& 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-<br>Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | Note 1 | N | Note 3 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | Note 1 | N | Note 3 |
| | Other (Urology) | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Peripheral<br>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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Other | |
| | Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal Imaging<br>& 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-<br>Card.) | | | | | | | | | | |
| | | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| | | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| | | Other (Urology) | | | | | | | | | | |
| | | Other (Ob/GYN) | | | | | | | | | | |
| Cardiac | | Cardiac Adult | | | | | | | | | | |
| | | Cardiac Pediatric | | | | | | | | | | |
| Peripheral<br>Vessel | | Peripheral vessel | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| | N = new indication; | | | P = previously cleared by FDA;<br>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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Other | |
| | Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal Imaging<br>& 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-<br>Card.) | | | | | | | | | | |
| | | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| | | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| | | Other (Urology) | | | | | | | | | | |
| | | Other (Ob/GYN) | | | | | | | | | | |
| Cardiac | | Cardiac Adult | | | | | | | | | | |
| | | Cardiac Pediatric | | | | | | | | | | |
| Peripheral<br>Vessel | | Peripheral vessel | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| | N = new indication; | | | P = previously cleared by FDA;<br>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<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Other | |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal Imaging<br>& 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-<br>Card.) | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| | Other (Urology) | | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | N | Note 3 | |
| | N = new indication; | P = previously cleared by FDA;<br>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<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Other | |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal Imaging<br>& 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<br>(Conventional) | | | | | | | | | | |
| | Musculo-skeletal<br>(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<br>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<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Other |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW | CW | Color | Power | Combined<br>Modes | Harmonic<br>Imaging | Other |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>& 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<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(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<br>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<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Other |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW | CW | Color | Power | Combined<br>Modes | Harmonic<br>Imaging | Other |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>& 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 | | | | | | | | | |
|…
