(98 days)
The ACCUVIX XG Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Intra-operative, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-recal, Trans-vaginal, Muscularive, Pedialit, Sinan Organis, Neonalia, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
The ACCUVIX XG is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler image and Colopher the Gala as B mode, W mode, W mode, Color Doppler imaging, 3D imaging mode (real time 4D ) imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The ACCUVIX XG also gives the operator the ability to measure anatomical structures and offers and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The ACCUVIX XC has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
This document is a 510(k) Premarket Notification summary for the ACCUVIX XG Diagnostic Ultrasound System and its associated transducers. It establishes substantial equivalence to previously cleared predicate devices rather than directly proving performance against acceptance criteria for a novel AI device. Therefore, much of the requested information regarding AI device-specific performance studies is not present.
Here's an breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify "acceptance criteria" in the context of performance metrics for an AI algorithm, nor does it report performance against such criteria. The device is a diagnostic ultrasound system seeking substantial equivalence to predicate devices, focusing on safety standards and intended uses.
The "performance" described relates to the device's adherence to various product safety standards. The document states:
"The ACCUVIX XG has been designed to met the following product safety standards:"
- UL 60601-1, Safety requirements for Medical Equipment
- CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
- EC60601-2-37, Diagnostic Ultrasound Safety Standards
- EN/IEC60601-1, Safety requirements for Medical Equipment
- NEMALID -1-2, EMC requirements for Medical Equipment
- NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- IEC 61157, Declaration of the acoustic output
- ISO10993-1, Biocompatibility
2. Sample size used for the test set and the data provenance
Not applicable. This is a traditional medical device submission (ultrasound system), not an AI device that would typically involve a test set for algorithm performance evaluation. The "test set" in this context would refer to internal validation of adherence to safety and performance standards, likely using physical testing on the device itself and its components, rather than a dataset of patient images. Data provenance (country of origin, retrospective/prospective) is not relevant to this type of device submission for demonstrating substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As this is not an AI device requiring ground truth for algorithm performance, no experts were used in this specific context for establishing ground truth of a test set. The validation would be against established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is mentioned, as this is related to a traditional medical device demonstrating substantial equivalence, not an AI algorithm evaluation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI device, so no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The ACCUVIX XG is a diagnostic ultrasound system, which inherently involves a human operator (human-in-the-loop) for image acquisition, interpretation, and diagnosis. It is not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As this document pertains to the substantial equivalence of an ultrasound imaging device, the "ground truth" relates to compliance with engineering, safety, and acoustic output standards, rather than clinical diagnoses established by expert consensus, pathology, or outcomes data for an AI algorithm.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no mention of a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI device, there is no training set mentioned, and therefore no method for establishing ground truth for a training set.
{0}------------------------------------------------
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
FEB 2 5 2011
This summary of safety and effectiveness is provided as part of this Premarket Notification in
compliance with 21 CER. Port 807, Submort E. Section 807, 20 compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1. Submitter's Information: 21 CFR 807.92(a)(1)
MEDISON CO., LTD. 1003, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea
Contact Person: Kyeong-Mi, Park Regulatory Affairs Manager
| Telephone: | 82.2.2194.1373 |
|---|---|
| Facsimile: | 82.2.556.9209 |
Data Prepared: August 12, 2010
2. Name of the device:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
ACCUVIX XG Diagnostic Ultrasound System
| Classification Names: | FR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
| Ultrasound Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX |
3. Identification of the predicate or legally marketed device:
K101455, EKO 7 Diagnostic Ultrasound System K092159, ACCUVIX V20 Diagnostic Ultrasound System
510(k) Summary / Statement Certification
{1}------------------------------------------------
4. Device Description:
The ACCUVIX XG is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler image and Colopher the Gala as B mode, W mode, W mode, Color Doppler
imaging, 3D imaging mode (real time 4D ) imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The ACCUVIX XG also gives the operator the ability to measure anatomical structures and offers and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The ACCUVIX XC has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The ACCUVIX XG has been designed to met the following product safety standards:
- UL 60601-1, Safety requirements for Medical Equipment
- CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
- EC60601-2-37, Diagnostic Ultrasound Safety Standards
- EN/IEC60601-1, Safety requirements for Medical Equipment
- NEMALID -1-2, EMC requirements for Medical Equipment
- NEMA UD-2, Acoustic Output Measurement Stadiard for Diagnostic Ultrasound Equipment
- NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- IEC 61157, Declaration of the acoustic output
- ISO10993-1, Biocompatibility
5. Intended Uses:
The ACCUVIX XG Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Intra-operative, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-recal, Trans-vaginal, Muscularive, Pedialit, Sinan Organis, Neonalia, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
6. Technological Characteristics:
The ACCUVIX XG is substantially equivalent to the ACCUVIX V20 Diagnostic Ultrasound System, cleared via K092159, and the EKO 7 Diagnostic Ultrasound System, cleared via K101455. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.
END of 510(K) Summary
510(k) Summary / Statement Certification
ATTACHEMENT I
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
FEB 2 5 2011
Re: K103397
Trade/Device Name: ACCUVIX XG Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, ITX, and IYN Dated: February 8, 2011 Received: February 10, 2011
Dear Mr. Job:
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 XG Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| C1-4EC | VR5-9 | P2-4BA | V5-9 |
|---|---|---|---|
| C2-61C | L3-8 | P3-8CA | V6-12 |
| C4-9/10ED | L5-131S | P4-12 | CW2.0 |
| ER4-9/10ED | LF5-12 | 3DC2-6 | CW4.0 |
| EV4-9/10ED | LS5-13 | V4-8 |
{3}------------------------------------------------
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality 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 letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Paul Hardy at (301) 796-6542.
Sincerely Yours,
Mary Stott
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
SECTION 1.3 INDICATIONS FOR USE
510(k) Number (if known):
Device Name: ACCUVIX XG Diagnostic Ultrasound System
The ACCUVIX XG Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeietal (Conventional, Superficial), Cardian Cephalia, Capaciti Cardiac Pediatric, Peripheral vessel
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Patel
(Division Sign-Off)
Indications for Use
Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Concession LCD ココ ヘ ヘ ヘ ヘ ヘ
{5}------------------------------------------------
510(k) No .:
Device Name: ACCUVIX XG Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: ("linical A
| 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) | N | N | N | N | N | Note I | Notes 2, 7, 8 |
| Abdominal | N | N | N | N | N | Note I | Notes 4, 7 | |
| Intra-operative (See Note 6) | N | N | N | N | Note I | Notes 8, 9 | ||
| Intra-operative (Neuro.) | N | N | N | N | Note I | Notes 8, 9 | ||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | Note I | Note 2, 5, 6, 7, 8, 9, 10 | ||
| Small Organ (See Note 5) | N | N | N | N | Note I | Note 2, 5, 6, 7, 8, 9, 10 | ||
| Neonatal Cephalic | N | N | N | N | Note I | Note 2, 7, 8, 9 | ||
| Adult Cephalic | N | N | N | N | N | Note I | Note 4, 7 | |
| Trans-rectal | N | N | N | N | Note I | Note 2, 7, 8, 10 | ||
| Trans-vaginal | N | N | N | N | Note I | Note 2, 7, 8, 10 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | Note I | Note 2, 5, 6, 7, 8, 9, 10 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | Note I | Note 2, 5, 6, 7, 8, 9, 10 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | Note I | Note 4, 7 |
| Cardiac Pediatric | N | N | N | N | N | Note I | Note 4, 7 | |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | Note I | Note 2, 5, 6, 7, 9, 10 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note I : B+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+C+M, Dual B, Dual B+C, Dual B+C, Dual B+C, Dual B+PD
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
Note 10: ElastoScan
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mary S Pastl
(Division Sign-Off)
Division of Magiclogical Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Section 1.3, page 2
{6}------------------------------------------------
510(k) No.:
Device Name: Ci-4EC for use with ACCUVIX XG
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 | ColorDoppler* | 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.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K101455; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Notel : B+M, B+PV, B+C', B+PD, B+C'+PW, B+C+PW, B+C+M, Dual B, Dual B+C, Dual B+C, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode
NOTE 4. COLOR MIXING
Note 5: I've example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatul patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging
Note B. 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mary Shatt
(Division Sign-Off)
Indications for Use
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
{7}------------------------------------------------
510(k) No .:
Device Name: C2-6IC for use with ACCUVIX XG
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Annocation
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | 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 I | 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.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) | ||||||||
N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E
Additional Comments:
Color Doppier includes Power (Amplitude) Doppier
Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M Dual F
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+PD+PW, B+C+M, Dual B+C, Dual B+C, Dual B+PD 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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mary S. Patel
(Division Sign-Off)
ion of Radiological Diagnostic Device Evaluation and Safety
Section 1.3, page 4
10K 10397
{8}------------------------------------------------
510(k) No.:
Device Name: C4-9/10ED for use with ACCUVIX XG
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Anolication
| Mode of Operation (*includes simultaneous B-mode) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal (See Note 3) | P | P | P | P | Note I | Notes 2, 7, 8 | |||
| Abdominal | P | P | P | P | Note I | Notes 2, 7, 8 | |||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note I | Notes 2, 7, 8 | |||
| Small Organ (See Note 5) | P | P | P | P | Note I | Notes 2, 7, 8 | |||
| Neonatal Cephalic | P | P | P | P | Note I | Notes 2, 7, 8 | |||
| 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.) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note I | Notes 2, 7, 8 | ||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note I: B+M, B+PW, B+C+PW, B+C+PW, B+C+PW, B+PD+PW, B+C+M, Dual B+C, Dual B+C, Duul B+PD, Duul B+PD, Duul B+PD, Duul B+PD, Duul B+PD, Duul B+PD, Duul B+PD, Duul B+PD, Duul B+
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: I've 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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mary Statts
(Division Sign-Division of Radiological De Vitro Diagnostic Device Evaluation and Safety Office of In
Indications for Use
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safe
{9}------------------------------------------------
510(k) No.:
Device Name: ER4-9/10ED for use with ACCUVIX XG
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Annlication
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | 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 | P | P | P | P | Note I | Note 2, 7, 8 | ||
| Trans-vaginal | P | P | P | P | Note I | Note 2, 7, 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.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+C+PW, B+C+PW, B+C+PW, B+C+M, Dual B, Dual B+C, Dual B+C, Dual B+PD
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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mary S Patel
(Division Sign-Off)
Olvision of Radiological Devioss o Diagnosuc Device Evaluation and Safety
Section 1.3, page 6
{10}------------------------------------------------
510(k) No .:
Device Name: EV4-9/10ED for use with ACCUVIX XG
Intended Use. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Annlication
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | 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) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | Note I | Note 2, 7, 8 | ||
| Trans-vaginal | P | P | P | P | Note I | Note 2, 7, 8 | ||
| 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.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppier
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+C+M, Dual B, Dual B+C, Dual B+C, Dual B+C, Dual B+PD
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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Munu S. Patil
(Division Sign-Off)
Division of Aagliological Devices Vitro Diagricstic Dovice Evaluation and Safety
Section 1.3, page 7
510K 10397
{11}------------------------------------------------
510(k) No .: Device Name: VR5-9 for use with ACCUVIX XG
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application
| General(Track I only) | Clinical ApplicationSpecific(Tracks I & III) | B | M | PWD | CWD | Mode of Operation (includes simultaneous B-mode)ColorDoppler | 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) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | Note 1 | Note 2, 7, 8, 10 | ||
| Trans-vaginal | N | N | N | N | Note 1 | Note 2, 7, 8, 10 | ||
| 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.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C; B+PD, B+C+PW, B+C+PW, B+C+M, Dual B, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+PD
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 Hannonic Imaging (THI)
Note 8: 3D imaging
·
Note 9: Panoramic imaging
Note10: ElastoScan
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mary S. Postell
(Division Sign Off)
Indications for Use
(Division Sign-Division of Radiological Devices Diagnostic Device Evaluation and Safety
{12}------------------------------------------------
510(k) No.: Device Name: L3-8 for use with ACCUVIX XG Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & II) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal (See Note 3) | |||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | ||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | ||
| Neonatal Cephalic | Note 2, 5, 6, 7, 9 | |||||||
| 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, 7, 9 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K101455; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+C+M, Dual B, Dual B+C, Dual B+C, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: I'or 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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mury Stattl
(Division Sign-Off)
ign of Radiological Devices Device Evaluation and Safety
Section 1.3, page 9
{13}------------------------------------------------
510(k) No.: Device Name: L5-131S for use with ACCUVIX XG 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 | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | ||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | ||
| 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, 7, 9, 10 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+CW, B+CW, B+CW, B+C+PW, B+C+M, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+PD
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
Note10: ElastoScan
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mary Sasted
(Division Sign-Off)
Indications for Use
Division of Rediological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
{14}------------------------------------------------
510(k) No.:
Device Name: LF5-12 for use with ACCUVIX XG
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 | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | ||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | ||
| 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, 7, 9, 10 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: 8+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+C+M, Dual B, Dual B+C, Dual B+C, Duul B+PD
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
Note10: LiastoScan
Concurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mary Stat
on of Redininguest No
Section 1.3, page 11
{15}------------------------------------------------
510(k) No .:
Device Name: LS5-13 for use with ACCUVIX XG
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 | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | P | P | P | P | Note I | Note 8, 9 | ||
| Intra-operative (Neuro.) | P | P | P | P | Note 1 | Note 8, 9 | ||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note 1 | Note 8, 9 | ||
| Small Organ (See Note 5) | P | P | P | P | Note I | Note 8, 9 | ||
| Neonatal Cephalic | P | P | P | P | Note 1 | Note 8, 9 | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note I | Note 8, 9 | ||
| Musculo-skel. (Supertic.) | P | P | P | P | Note I | Note 8, 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note I | Note 5, 6, 9 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K093849; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+C+M, Dual B+C, Dual B+C, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follivle 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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mary Shattell
(Division Sign-Off)
on of Radiological Devices agnostic Device Evaluation and Safety
Section 1.3, page 12
{16}------------------------------------------------
510(k) No.:
Device Name: P2-4BA for use with ACCUVIX XG
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 | ColorDoppler* | 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& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| 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 Adult | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+C+M, Dual B, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: I be example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
510
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mary Stotel
(Division Sign-Off)
Division of Rachological Devices Office of in fitro Diagnostic Device Evaluation and Safety
Section 1.3, page 13
{17}------------------------------------------------
510(k) No.: Device Name: P3-8CA for use with ACCUVIX XG
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clini..... A
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | P | P | P | P | P | Note I | 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 | P | P | P | P | P | Note I | 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 | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note I | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note I : B+M, B+PW, B+C', B+PD, B+C'+PW, B+C+PW, B+C+M, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: I've 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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Aladiological Devices
Section 1.3, page 14
Indications for Use
Office of In Vitro Diagnostic Device Evailuation and Safety
{18}------------------------------------------------
510(k) No .:
Device Name: P4-12 for use with ACCUVIX XG
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | 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& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | P | P | P | P | P | Note 1 | Note 4, 7 | |
| 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 Adult | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K101455; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note I: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+C+M, Dual B, Dual B+C, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: includes infertility monitoring of follivele development
Note 4: Color M-mode
Note 5: I'or 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
Indications for Use
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mary Shatt
(Division Sign-Off)
Division of Raulciogical Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K 103397
{19}------------------------------------------------
510(k) No.:
Device Name: 3DC2-6 for use with ACCUVIX XG
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 & II) | B | M | PWD | CWD | ColorDoppler* | 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.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K093714; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C', B+PD, B+C+PW, B+C+PW, B+C+M, Dual B, Dual B+C, Dual B+C, Dual B+C, Dual B+PD
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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mary Statts
(Division Sign-Off)
Division of Realological Devices Office of Evaluation and Safety
Section 1.3, page 16
{20}------------------------------------------------
510(k) No.:
Device Name: V4-8 for use with ACCUVIX XG
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 | ColorDoppler* | 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) | ||||||||
| 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 Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N= new indication: P= previously cleared by FDA K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note I: B+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+PD+PW, B+C+M, Dual B, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: I've 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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mung Stattl
(Division Sign-Off)
Division Sign-Off Division of Hadloiggical Devices or Device Evaiuation and Sefery Office of It
510K /D2397
Indications for Use
{21}------------------------------------------------
510(k) No .:
Device Name: V5-9 for use with ACCUVIX XG
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 | ColorDoppler* | 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 | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| Trans-vaginal | P | P | P | P | Note 1 | Note 2, 7, 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.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication: P= previously cleared by FDA K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+C+M, Dual B, Dual B+C, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infectility monitoring of follicle development
Note 4: Color M-mode
Note 5: I'or 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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mary Stetel
(Division Sign-Off)
(Division Sign Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Section 1.3, page 18
{22}------------------------------------------------
510(k) No .:
Device Name: V6-12 for use with ACCUVIX XG
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 | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note I | Note 2, 5, 6, 7, 9 | ||
| Small Organ (See Note 5) | P | P | P | P | Note I | Note 2, 5, 6, 7, 9 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note I | Note 2, 5, 6, 7, 9 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note I | Note 2, 5, 6, 7, 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note I | Note 5, 6, 7, 9 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+C+M, Dual B, Dual B+C, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: I've 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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Maree Skalitzky
(Division Sign Off)
livision of Ragiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K /03392
ection 1.3, page 19
Indications for Use
{23}------------------------------------------------
510(k) No.:
Device Name: CW2.0 for use with ACCUVIX XG
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) | U | M | PWD | CWD | ColorDoppler* | 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) | ||||||||
| 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 | Cardiac Adult | P | ||||||
| Cardiac Pediatric | P | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | ||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note I: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+C+M, Dual B, Dual B+C, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: I'or 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
Concurrence of CDRII, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mary Statt
Indications for Use
Division of Radioingical Devices Office of In Vitro Division of Hacloingiour Soviets
Office of In Vitro Diagnostic Device Evaluation and Safety
{24}------------------------------------------------
510(k) No.: Device Name: CW4.0 for use with ACCUVIX XG
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 | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal (See Note 3) | |||||||||
| Abdominal | |||||||||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | P | ||||||||
| 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.) | |||||||||
| PeripheralVessel | Peripheral vessel | P | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+C+M, Dual B, Dual B+C, Duul B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes intertility monitoring of follicle development
Note 4: Color M-mode
Note 3: I'or 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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Indications for Use
on of Anopical Devices nostic Device Evaluation and Safety
510K 103397
§ 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.