(14 days)
Not Found
No
The provided text does not mention AI, ML, or any related terms or concepts. The description focuses on standard ultrasound imaging modes and analysis packages.
No
The device is described as a "diagnostic ultrasound imaging" system, and its function is to "acquire ultrasound data and to display the data" and provide "measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes." None of the descriptions mention any therapeutic action or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system and transducers are "intended for diagnostic ultrasound imaging and fluid analysis of the human body." The "Device Description" further clarifies that it is a "diagnostic ultrasound system" and provides "analysis packages that provide information used for clinical diagnostic purposes."
No
The device description explicitly states it is a "diagnostic ultrasound system" and mentions "transducers" and a "CRT display," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid analysis of the human body." This describes a device that uses physical principles (ultrasound waves) to create images and perform measurements within the body.
- Device Description: The description details how the system acquires and displays ultrasound data in various modes and provides measurement and analysis packages. This aligns with the function of an ultrasound imaging system.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens outside the body, such as blood, urine, or tissue samples, to provide information about a person's health. This device does not mention any such function or the analysis of biological specimens.
Therefore, the ACCUVIX XQ system is a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ACCUVIX XQ ™ system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal (including infertility monitoring of follicle development), Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Transesophageal, Muscular-skeletal, Urology, TCD, Cardiac (Adult, Pediatric), and Peripheral-vascular (Carotid, Arterial, Venous) applications.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
The ACCUVIX XQ "M is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging, Harmonic imaging, and PW Spectral Doppler mode on the CRT display. It also provides the 3I) imaging mode using the 3D probe in the Mechanical scan mode.
The ACCUVIX XQ ™ has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Transesophageal, Muscular-skeletal, Urology, Cardiac (Adult, Pediatric), Peripheral-vascular (Carotid, Arterial, Venous), Ophthalmic, Thyroid, Breast, Scrotum, Penis
Indicated Patient Age Range
Adult, Pediatric, Neonatal
Intended User / Care Setting
Competent health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
0C1 3 1 2005
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Prepared March 28, 2005
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1. Submitter's Information: 21 CFR 807.92(a)(1)
Mr. Kyung-Am, Shim Regulatory Affairs Manager Medison Co. Ltd. 997-10, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea 82.2.2194.1381 Telephone: 82.2.2194.1399 Facsimile: kashim@medison.com Email:
2. Name of the device:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
ACCUVIX XQ TM Diagnostic Ultrasound System and Transducers
| Classification Names: | FR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasound Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
3. Identification of the predicate or legally marketed device:
Medison Co., Ltd. believes that ACCUVIX XQ ™ ultrasound system is substantially equivalent to the currently marketed SONOACE 9900 PLUS ultrasound system (K032329) and SONOACE 9900 ultrasound system (K012867 and K002185)
4. Device Description:
The ACCUVIX XQ "M is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging, Harmonic imaging, and PW Spectral Doppler mode on the CRT display. It also provides the 31) imaging mode using the 3D probe in the Mechanical scan mode.
The ACCUVIX XQ ™ has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The
1
system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.
The ACCUVIX XQ ™ has been designed to meet the following electromechanical safety standards:
- UL 60601-1, Underwriters Laboratories Standards, Medical Electrical Equipment
- C22.2 No. 601.1, Canadian Standards Association, Medical Electrical Equipment
- EN 60601-1, European Norm, Medical Electrical Equipment
- EN 60601-1-2, European Norm, Collateral Standard: Electromagnetic Compatibility .
- IEC 61157, International Electrotechnical Commission, Requirements for the । declaration of the acoustic output of medical diagnostic ultrasonic equipment
- ISO10993, Biological evaluation of medical devices –
3. Intended Uses:
The ACCUVIX XQ ™ system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include:
Fetal (including infertility monitoring of follicle development), Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Transesophageal, Muscular-skeletal, Urology, TCD, Cardiac (Adult, Pediatric), and Peripheral-vascular (Carotid, Arterial, Venous) applications.
6. Technological Characteristics:
The ACCUVIX XQ TM is substantially equivalent to the SA-9900 PLUS Diagnostic Ultrasound System, cleared via K032329, and the SA-9900 Diagnostic Ultrasound System, cleared via K002185 and K012867. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.
7. Conclusion:
The ACCUVIX XQ™ 510(k) Pre-Market Notification contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
ACCUVIX XO™ will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Moderate"
END of 510(K) Summary
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
OCT 3 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medison Co., Ltd. % Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Serves NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K052911
Trade Name: ACCUVIX XQTM Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: October 14, 2005 Received: October 17, 2005
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the ACCUVIX XQ™ Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
3D3-5EK Curved Array 3D4-7EK Curved Linear Array 3D5-8EK Curved Linear Array C2-61C Curved Array
3
C3-7IM Curved Array C5-2EL Curved Array CW2.0 Static CW CW4.0 Static CW EC4-9IS Curved Array L5-9EE Linear Array L5-12IM Linear Array L6-12IS Linear Array L8-I5IS Linear Array
MPT4-7AO Multiplane TEE P2-4AC Phased Array P3-5AC Phased Array P3-7AC Phased Array VAW3-5 Curved Array VAW4-7 Curved Array CDW5-8 Curved Array VNA6-12 Linear Array
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancyc Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
510(k) No .:
Section 4.3 INDICATIONS FOR USE
DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT
| ACCUVIX XQTM Diagnostic Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|
| Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | N | N | N | N | N | Note 1 | Notes 2, 7, 8 | |
| Abdominal | N | N | N | N | N | Note 1 | Notes 2, 7, 8 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | Note 1 | Note 2,4,5,6,7,8,9 | |
| Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2,5,6,8,9 | |
| Neonatal Cephalic | N | N | N | N | N | Note 1 | ||
| Adult Cephalic | N | N | N | N | N | Note 1 | Note 4. 7 | |
| Trans-rectal | N | N | N | N | N | Note 1 | Note 2, 3, 8 | |
| Trans-vaginal | N | N | N | N | N | Note 1 | Note 2, 3. 8 | |
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | N | N | N | N | N | Note 7. 8 | ||
| Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Note 2.5.6.8.9 | |
| Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 2.5.6.8.9 | |
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | Note 1 | Note 4. 7 |
| Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4. 7 | |
| Trans-esophageal (Cardiac) | N | N | N | N | N | Note 1 | Note 7. 8 | |
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 5. 6, 9 |
| Other (spec.) | N |
N= new indication: P= previously cleared: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppler Interdes Porter (Ampilate) (1997) - 1976)
Note 1 : B/M. B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, serotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 31) imaging
Note 9: Panoramic inkaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Davie Reardon
and Radiolo 510(k) Num
6
| 510(k) No .: | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System | ||||||||
| Transducer: | 3D3-5EK Curved Linear Array | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal (See Note 3) | N | N | N | N | Note 1 | Notes 2, 7, 8 | |||
| Abdominal | N | N | N | N | Note 1 | Notes 2, 7, 8 | |||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent) | |||||||||
| Musculo-skel (Supertic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication: P= previously cleared: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/ B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: theroid, parathyroid, breast, scrotum and penis in adult, pediatrie and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 31) imaging
Note 9: Panoramic imaging
Nancy broadon
(Division Sign-Off) ()
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052911
7
| 510(k) No.: | |
|---|---|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System |
| Transducer: | 3D4-7EK Curved Linear Array |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | ||||||||
| Fetal (See Note 3) | N | N | N | N | Note I | Notes 2, 7, 8 | ||
| Abdominal | N | N | N | N | Note 1 | Notes 2, 7, 8 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1 : B/M. B/I/W Doppler, B/Color Doppler/PW Doppler, B/Power Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediative and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 31) imaging
Note 9: Panoramic imaging
Nansy rogo
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 1052011
Radiological Devices
510(k) Number K0529
8
| 510(k) No.: | |
|---|---|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System |
| Transducer: | 3D5-8EK Curved Linear Array |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | |||||||||
| Fetal (See Note 3) | |||||||||
| Abdominal | |||||||||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | Note 1 | Notes 2. 8 | |||
| Trans-vaginal | N | N | N | N | Note 1 | Notes 2. 8 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1 : B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler. B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example; thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 31) imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
and Radiological Devices
510(k) Number
Nancyc Beagdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
9
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System | |||||||
| Transducer: | C2-6IC Curved Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | P | P | P | P | Note 1 | Notes 2, 7, 8 | ||
| Abdominal | P | P | P | P | Note 1 | Notes 2, 7, 8 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note 1 | Notes 2. 7, 8 | ||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication: P= previously cleared: E== added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Nate 1: 13/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler. B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatic and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D) imaging
Note 9: Panoramic imaging
Nancyc burgdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 4052911
10
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | ACCUVIX XQ TM Diagnostic Ultrasound System | |||||||
| Transducer: | C3-7IM Curved Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 7, 8 | |
| Abdominal | P | P | P | P | Note 1 | Notes 2, 7, 8 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note 1 | Notes 2, 7, 8 | ||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication: P - previously cleared; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppler, B/Color Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler. B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 31) imaging
Note 9: Panoramic imaging
Nancy C. Hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
Radiological Devices `/6R291/
11
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System | |||||||
| Transducer: | C5-2EL Curved Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | N | N | N | N | N | Note 1 | Notes 2, 7, 8 | |
| Abdominal | N | N | N | N | Note 1 | Notes 2, 7, 8 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | Note 1 | Notes 2, 7, 8 | ||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication: P= previously cleared; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1 : B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/ B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Nancy C. Brandon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
- Number
K052911
12
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System | |||||||
| Transducer: | ||||||||
| CW2.0 Static CW | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P | |||||||
| Cardiac | Cardiac Pediatric | P | ||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | ||||||
| Other (spec.) | P |
N= new indication; P= previously cleared; E= added under Appendix F.
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 31) imaging
Note 9: Panoranuc imaging
Nancyc Brandon
(Division S Division of Reproc and Radiological Devices : )
13
| 510(k) No.: | ACCUVIX XQ ™ Diagnostic Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| System: | CW4.0 Static CW | ||||||||
| Transducer: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Intended Use: | Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Other | Fetal (See Note 3) | ||||||||
| Abdominal | |||||||||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | N | |||||||
| Cardiac Pediatric | N | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | N | |||||||
| Other (spec.) | N |
N= new indication; P= previously cleared: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler. B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 31) imaging
Note 9: Panoramic imaging
(Division Sid Division of Reproduc ve, A and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
14
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System | |||||||
| Transducer: | EC4-9IS Curved Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
| General | ||||||||
| (Track 1 only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | P | P | P | P | Note 1 | Note 2. 8 | ||
| Trans-urethral | P | P | P | P | Note 1 | Note 2. 8 | ||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppler. B/Color Doppler. B/Color Doppler/PW Doppler. B/Power Doppler/PW Doppler/PW Doppler. B/Color Doppler/Color M
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 31) imaging
Note 9: Panoramic imaging
Nancy C. Hogdon
(Division Sign-Off)
Division of Reproductive, Abdor m: Padiological Devices the ke Member ________________________________________________________________________________________________________________________________________________________________
15
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | ACCUVIX XQ TM Diagnostic Ultrasound System | |||||||
| Transducer: | L5-9EE Linear Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | Other | ||||||
| (Spec.) | ||||||||
| B | M | PWD | CWD | Color | ||||
| Doppler* | Combined* | |||||||
| (Spec.) | ||||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal (See Note 3) | |||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | Note 1 | Note 2, 8, 9 | ||
| Small Organ (See Note 5) | N | N | N | N | Note 1 | Note 2, 8, 9 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | Note 1 | Note 2, 8, 9 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 2, 8, 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication: P= previously cleared: E = added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppier Includes Poster (Ampliade) Hoppier/PW Doppler/PW Doppler/PW Doppler/PW Doppler. B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: Color Mentode
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonie Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Nancyc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
K632911
16
| 510(k) No.: | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System | ||||||||||
| Transducer: | L5-12IM Linear Array | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||||
| General | |||||||||||
| (Track I only) | Specific | ||||||||||
| (Tracks 1 & III) | B | M | PWD | CWD | Color | ||||||
| Doppler* | Combined* | ||||||||||
| (Spec.) | Other | ||||||||||
| (Spec.) | |||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal (See Note 3) | |||||||||||
| Abdominal | |||||||||||
| Intra-operative (See Note 6) | |||||||||||
| Intra-operative (Neuro.) | |||||||||||
| Fetal Imaging | Laparoscopic | ||||||||||
| & Other | Pediatric | P | P | P | P | Note 1 | Note 2, 5, 6. 9 | ||||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2. 5. 6. 9 | |||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Cardiac) | |||||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2. 5. 6. 9 | |||||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2. 5. 6. 9 | |||||
| Intra-luminal | |||||||||||
| Other (spec.) | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac | Cardiac Pediatric | ||||||||||
| Trans-esophageal (Cardiac) | |||||||||||
| Other (spec.) | |||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | Note 1 | Note 5. 6. 9. 10 | ||||
| Vessel | Other (spec.) |
N= new indication: P= previously cleared: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Dopper Includes Poser (rumplande) Hogiler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/ B/Color Doppier/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: Eoror without
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 31) imaging
Note 9: Panoramic imaging
Nancyc broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
Radiological Devices
Ek Number
K052911
17
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | ACCUVIX XQ TM Diagnostic Ultrasound System | |||||||
| Transducer: | L6-12IS Linear Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | Note 1 | Note 2, 5, 6, 9 | ||
| Small Organ (See Note 5) | N | N | N | N | Note 1 | Note 2, 5, 6, 9 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | Note 1 | Note 2. 5. 6. 9 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 2. 5. 6. 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | Note 1 | Note 5. 6. 9 | |
| Other (spec.) |
N= new indication; P= previously cleared: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppler Internet Princiate) Longiler. B/Color Doppler. B/Power Doppler/PW Doppler/PW Doppler. B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3 : Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Nancy C. Hodgson
(Division Sign-Off)
sion of Reproductive, Abdominal,
siological Devices
KU524
18
| 510(k) No.: | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| System: | ACCUVIX XQ TM Diagnostic Ultrasound System | |||||||||
| Transducer: | L8-15IS Linear Array | |||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||||
| General | ||||||||||
| (Track I only) | Specific | |||||||||
| (Tracks 1 & III) | B | M | PWD | CWD | Color | |||||
| Doppler* | Combined* | |||||||||
| (Spec.) | Other | |||||||||
| (Spec.) | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal (See Note 3) | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (See Note 6) | ||||||||||
| Intra-operative (Neuro.) | ||||||||||
| Fetal Imaging | Laparoscopic | |||||||||
| & Other | Pediatric | N | N | N | N | N | Note 1 | Note 2, 5, 6, 9 | ||
| Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2, 5. 6, 9 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Cardiac) | ||||||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Note 2. 5. 6, 9 | |||
| Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 2. 5. 6.9 | |||
| Intra-luminal | ||||||||||
| Other (spec.) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | Note 1 | Note 5. 6. 9 | ||
| Vessel | Other (spec.) |
N= new indication: P= previously cleared: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppler Includes Porce (Ampilate) (106) Per Per Par Poppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Dopple B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Yauric berger
Division Sign-Off
Division of Reproductive, Abdominal,
and Radiological Devices
19
| 510(k) No .: | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| System: | ACCUVIX XQ TM Diagnostic Ultrasound System | |||||||||||
| Transducer: | MPT4-7AO Multiplane TEE | |||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||||||
| General | ||||||||||||
| (Track I only) | Specific | |||||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||||||
| Doppler* | Combined* | |||||||||||
| (Spec.) | Other | |||||||||||
| (Spec.) | ||||||||||||
| Ophthalmic | Ophthalmic | |||||||||||
| Fetal (See Note 3) | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (See Note 6) | ||||||||||||
| Intra-operative (Neuro.) | ||||||||||||
| Fetal Imaging | Laparoscopic | |||||||||||
| & Other | Pediatric | |||||||||||
| Small Organ (See Note 5) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Cardiac) | N | N | N | N | N | Note I | Note 7. 8 | |||||
| Musculo-skel. (Convent.) | ||||||||||||
| Musculo-skel. (Superfic ) | ||||||||||||
| Intra-luminal | ||||||||||||
| Other (spec.) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac | Cardiac Pediatric | |||||||||||
| Trans-esophageal (Cardiac) | N | N | N | N | N | Note l | Note 7. 8 | |||||
| Other (spec.) | ||||||||||||
| Peripheral | Peripheral vessel | |||||||||||
| Vessel | Other (spec.) |
N= new indication: P= previously cleared: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppler Internet (Timpleote) (1) ) Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler.
B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrounn and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THD
Note 8: 31) imaging
Note 9: Panoramic imaging
Nancy C. Braydon
(Division Sign Off)
Division of Reproductive, Abdominal,
and Radiological Devices
(HHK) Number K052411
20
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System | |||||||
| Transducer: | P2-4AC Phased Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | N | N | N | N | N | Note 1 | Note 4. 7 | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4. 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication: P= previously cleared: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppler Includes Poller (Anglades) Weler Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler. B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatic and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Nancy Beagdon
Division ! Invision of Renrodi P. Redinlogical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | N | N | N | N | N | Note 1 | Note 4, 7, 10 | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4, 7, 10 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication: P= previously cleared: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppler Includes Porter (Anpacace) Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/ B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediativ and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Nancy Gordon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K152911
22
:
| 510(k) No.: | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| System: | ACCUVIX XQ TM Diagnostic Ultrasound System | |||||||||
| Transducer: | P3-7AC Phased Array | |||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||||
| General | ||||||||||
| (Track I only) | Specific | |||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||||
| Doppler* | Combined* | |||||||||
| (Spec.) | Other | |||||||||
| (Spec.) | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal (See Note 3) | ||||||||||
| Abdominal | P | P | P | P | P | Note 1 | Note 4, 7 | |||
| Intra-operative (See Note 6) | ||||||||||
| Intra-operative (Neuro.) | ||||||||||
| Fetal Imaging | Laparoscopic | |||||||||
| & Other | Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | ||
| Small Organ (See Note 5) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | Note 1 | Note 4, 7 | |||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Cardiac) | ||||||||||
| Musculo-skel. (Convent.) | ||||||||||
| Musculo-skel. (Superfic.) | ||||||||||
| Intra-luminal | ||||||||||
| Other (spec.) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4. 7. 10 | |||
| Trans-esophageal (Cardiac) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1 : B/M, B/PW Doppler, B/Color Doppler/PW Doppler, B/Power Doppler/PW Doppler/PW Doppler. B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Nancy C. Hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K152911
23
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Other | Fetal (See Note 3) | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| Abdominal | P | P | P | P | Note 1 | Note 2, 7, 8 | |||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | Note 1 | Note 2, 7, 8 | |||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication: P= previously cleared: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler, B/Power Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatrie and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 31) imaging
Note 9: Panoranne imaging
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
Radiological Devices
K162911
Number
24
| 510(k) No .: | |
|---|---|
| System: | ACCUVIX XQ TM Diagnostic Ultrasound System |
| Transducer: | VAW4-7 Curved Array |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal ( See Note 3 ) | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| Abdominal | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| Intra-operative ( See Note 6 ) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| Small Organ ( See Note 5 ) | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M. B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler. B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4. Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 31) imaging
Note 9: Panoramic imaging
Nancy C. Snogdon
sion of Reproductive, Abdominal
K05291
25
| 510(k) No.: | |
|---|---|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System |
| Transducer: | VDW5-8 Curved Array |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* | ||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | ||||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | P | P | P | P | Note 1 | Note 2, 8 | ||
| Trans-urethral | P | P | P | P | Note 1 | Note 2, 8 | ||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication: P= previously cleared; E- added under Appendix f:
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler, B/Power Dappler/PW Doppler/PW Doppler. B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4 Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatie and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note S. 3D imaging
Note 9: Panoramic imaging
Nancyi hogdon
Division Sign-Off
Division of Reproductive Abdominal
UC5231
26
| 510(k) No.: | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| System: | ACCUVIX XQ TM Diagnostic Ultrasound System | ||||||||
| Transducer: | VNA6-12 Linear Array | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Other | Fetal (See Note 3) | ||||||||
| Abdominal | |||||||||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 8 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2, 8 | |||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 8 | |||
| Intra-luminal | P | P | P | P | Note 1 | Note 2, 8 | |||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared: E+ added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertifity monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatrie and neanatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 31) imaging
Note 9. Panoramic imaging
Nancy C. Hogdon
Division Sign-Off
Division of Reproductive, Abdominal,
and Radiological Devices
K052911