(15 days)
The SONOACE X4 system is intended for the following applications: General, OB, Gynecology, Abdomen, Fetal Heart, Renal, Neonatal, Pediatric, Vascular, Cardiac, Urology, Breast, Small Parts, Vascular, Musculoskeletal applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The SONOACE X4 is a general purpose, mobile, software controlled, diagnostic ultrasound system with on-screen display for themal and mechanical indices related to potential bioeffect mechanisms.. Its function is to acquire ultrasound data and to display the data as 2D (B) mode, M mode, Power Doppler imaging, Harmonic imaging, or 3D imaging on the CRT display.
This appears to be a 510(k) premarket notification for a diagnostic ultrasound system (SONOACE X4) and its associated transducers. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo performance criteria through a clinical study with acceptance criteria.
Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment does not apply in the context of this specific regulatory submission.
Here's why and what can be inferred:
Why the requested information doesn't apply to this document:
- Substantial Equivalence (510(k)) Process: The 510(k) pathway is for devices that are "substantially equivalent" to a legally marketed predicate device. This means the new device has the same intended use and technological characteristics as the predicate, or has different technological characteristics but does not raise different questions of safety and effectiveness.
- Focus on Comparison, Not De Novo Performance: This document primarily identifies predicate devices (K012887, K043455) and asserts that the SONOACE X4 and its transducers are substantially equivalent. It lists safety standards (UL, CSA, IEC, NEMA, ISO) that the device meets, but these are general safety and performance standards for ultrasound equipment, not specific diagnostic acceptance criteria for a particular clinical task.
- Absence of Clinical Study Data for Acceptance Criteria: There is no mention of a clinical study designed to test the diagnostic performance of the SONOACE X4 against specific acceptance criteria (e.g., sensitivity, specificity for detecting a certain condition). The "Mode of Operation" tables simply indicate what modes (B, M, PWD, etc.) are available for each clinical application, and whether they are new ("N") or previously cleared ("P") based on predicate devices.
What can be extracted/inferred from the document given the request:
Since the document doesn't contain a study proving the device meets acceptance criteria in the way you've described for a diagnostic AI model, most of your requested fields will be "Not Applicable" or "Not Provided." However, here's an attempt to address each point based on the nature of this 510(k) submission:
Acceptance Criteria and Device Performance for SONOACE X4 Diagnostic Ultrasound System
This submission is a 510(k) premarket notification for the SONOACE X4 Diagnostic Ultrasound System, which aims to demonstrate "substantial equivalence" to previously cleared predicate devices, rather than establishing de novo performance acceptance criteria through a specific clinical study for diagnostic accuracy. Therefore, the concept of a "table of acceptance criteria and reported device performance" as typically associated with a diagnostic AI model study is not applicable here.
The device's "performance" is implicitly deemed acceptable by its substantial equivalence to predicate devices which have already been cleared for marketing. The acceptance criteria met are primarily related to safety and general device performance standards for diagnostic ultrasound equipment.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Type | Description / Standard Met | Reported Device Performance |
|---|---|---|
| General Safety and Electrical Safety | UL 60601-1, CSA C22.2 No. 601.1, EN/IEC60601-1 (Safety requirements for Medical Equipment) | Device designed to meet these standards (implied compliance). |
| EMC Requirements | EN/IEC60601-1-2 (EMC requirements for Medical Equipment) | Device designed to meet these standards (implied compliance). |
| Diagnostic Ultrasound Safety | IEC60601-2-37 (Diagnostic Ultrasound Safety Standards) | Device designed to meet these standards (implied compliance). |
| Acoustic Output Measurement and Display | NEMA UD 2-2004 (Acoustic Output Measurement Standard), NEMA UD 3-2004 (Real Time Display of Thermal and Mechanical Acoustic Output Indices), IEC 61157 (Declaration of Acoustic Output) | Device designed to meet these standards (implied compliance). |
| Biocompatibility | ISO10993 (Biocompatibility) | Device designed to meet these standards (implied compliance). |
| Intended Use Equivalence (Clinical Applications)¹ | Substantially equivalent to predicate devices K012887 (SA6000II) and K043455 (SA8000SE) for listed applications. | Able to acquire and display 2D (B) mode, M mode, Power Doppler imaging, Harmonic imaging, 3D imaging for a range of clinical applications (General, OB, Gynecology, Abdomen, Fetal Heart, Renal, Neonatal, Pediatric, Vascular, Cardiac, Urology, Breast, Small Parts, Musculoskeletal). |
| Technological Characteristics Equivalence | Substantially equivalent to predicate devices in transmitting/receiving ultrasonic energy and post-processing. | Performs post-processing of echoes to generate on-screen displays of anatomic structures and fluid flow. Allows specialized measurements and calculations. |
¹ Note: The tables provided in the document (from {5} to {14}) list clinical applications and modes of operation for the main system and each transducer. "N" indicates a new indication (compared to the specific predicate mentioned in the footer for that table), while "P" indicates previously cleared. This is a demonstration of equivalence for intended uses, not a performance study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This document does not describe a clinical study with a specific test set for diagnostic accuracy. The substantial equivalence argument relies on prior clearances of predicate devices and adherence to recognized standards.
- Data Provenance: Not applicable. No patient data (retrospective or prospective) from a specific test set is discussed in the context of diagnostic performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. No ground truth establishment for a diagnostic test set is described.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring ground truth adjudication is described.
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
- MRMC Study: Not applicable. This document is for a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop) performance was done
- Standalone Study: Not applicable. This document is for a diagnostic ultrasound system, which inherently involves human operation and interpretation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable. This document does not present a study requiring clinical ground truth for diagnostic accuracy.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. As an ultrasound imaging system (not an AI model within the scope of this submission), there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment for Training Set: Not applicable.
{0}------------------------------------------------
2006 JAN 3
510(k) Premarket Notification
SONOACE X4 Diagnostic Ultrasound System
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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)
Medison Co. Ltd. 997-10, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea
Contact Person:
Mr. Kyung-Am, Shim Regulatory Affairs Manager
| Telephone: | 82.2.2194.1381 |
|---|---|
| Facsimile: | 82.2.2194.1399 |
| Email: | kashim@medison.com |
Data Prepared:
November 10, 2005
2. Name of the device:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
SONOACE X4 Diagnostic Ultrasound System
| 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:
K012887, 09/12/2001, SA6000II Ultrasound system K043455, 12/21/2004, SA8000SE Ultrasound system
4. Device Description:
The SONOACE X4 is a general purpose, mobile, software controlled, diagnostic ultrasound system with on-screen display for themal and mechanical indices related to potential bioeffect mechanisms.. Its function is to acquire ultrasound data and to display the data as 2D (B) mode, M mode, Power Doppler imaging, Harmonic imaging, or 3D imaging on the CRT display.
{1}------------------------------------------------
The SONOACE X4 has been designed to meet the following product safety standards:
- UL 60601-1, Safety requirements for Medical Equipment -
- CSA C22.2 No. 601.1, Safety requirements for Medical Equipment -
- IEC60601-2-37, Diagnostic Ultrasound Safety Standards *
- EN/IEC60601-1, Safety requirements for Medical Equipment -
- EN/IEC60601-1-2, EMC requirements for Medical Equipment y -
- NEMA UD 2-2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound -Equipment
- NEMA UD 3-2004 Standard for Real Time Display of Thermal and Mechanical -Acoustic Output Indices on Diagnostic Ultrasound Equipment
- IEC 61157, Declaration of the acoustic output -
- ISO10993, Biocompatibility -
5. Intended Uses:
The SONOACE X4 system is intended for the following applications: General, OB, Gynecology, Abdomen, Fetal Heart, Renal, Neonatal, Pediatric, Vascular, Cardiac, Urology, Breast, Small Parts, Vascular, Musculoskeletal applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
6. Technological Characteristics:
The SONOACE X4 is substantially equivalent to the SA6000II Diagnostic Ultrasound System, cleared via K012887, and the SA8000 SE Diagnostic Ultrasound System, cleared via K043455. 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.
END of 510(K) Summary
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
JAN 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medison C., Ltd. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K053530
Trade Name: SONOACE X4 Diagnostic Ultrasound System Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: IYN Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: IYO Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Regulatory Class: II Dated: December 15, 2005 Received: December 19, 2005
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 SONOACE X4 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| HL5-9ED | L5-9EC | L5-9EE |
|---|---|---|
| C2-4ES | C2-5ET | C3-7ED |
| C4-9ED | EC4-9ED | EC4-9ES |
{3}------------------------------------------------
Page 2 - Mr. Mark Job
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) OF N F 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) commins anaseeptarre ratus () goduction 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 r ne speerly 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.
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
{4}------------------------------------------------
Page 3 - Mr. Mark Job
If you have any questions regarding the content of this letter, please contact Mr. Rodrigo Perez at (301) 594-1212.
Sincerely yours,
Daniel A. Chapman
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
{5}------------------------------------------------
510(k) Number:
Device Name: SONOACE X4 Diagnostic Ultrasound System
Device Name: "OONOROE A Diag fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler* | Power(Amp)Doppler | ColorVelocityImaging | Combined(Spec.) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | N | N | N | Notes 1 | Notes 3, 5, 6 | |||||
| Abdominal | N | N | N | Notes 1 | Notes 3, 5, 6 | |||||
| Intra-Operative(See Note 4) | N | N | N | Notes 1 | Notes 3, 5, 6 | |||||
| Intra-OperativeNeurological | ||||||||||
| Pediatric | N | N | N | Notes 1 | Notes 3, 5, 6 | |||||
| Small Organ(See Note 2) | N | N | N | Notes 1 | Notes 3, 5, 6 | |||||
| Neonatal Cephalic | N | N | N | Notes 1 | Note 5 | |||||
| Adult Cephalic | N | N | N | Notes 1 | Note 5 | |||||
| Cardiac | N | N | N | Notes 1 | Note 5 | |||||
| Transesophageal | Notes 1 | |||||||||
| Trans-Rectal | N | N | N | Notes 1 | Notes 3, 5 | |||||
| Trans-Vaginal | N | N | N | Notes 1 | Notes 3, 5 | |||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral -Vascular | N | N | N | Notes 1 | Note 5 | |||||
| Laparoscopic | ||||||||||
| Muscular-SkeletalConventional | N | N | N | Notes 1 | Notes 3, 5, 6 | |||||
| Muscular-SkeletalSuperficial | N | N | N | Notes 1 | Notes 3, 5, 6 | |||||
| Others(Specify) |
Mode of Operation
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
Note 1: B/M, B/PW Doppler
Note 1. B/M, B/P W Dopper
Note 2: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
Donald C. Hodgson
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
{6}------------------------------------------------
510(k) Number:
510(K) Namber .
Device Name: HL5-9ED for use with SONOACE X4
Device Name: HC9-5ED for use with SONONONOSA
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler* | Power(Amp)Doppler | ColorVelocityImaging | Combined(Spec.) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-Operative(See Note 4) | ||||||||||
| Intra-OperativeNeurological | Note 1 | Notes 3, 5 | ||||||||
| Pediatric | P | P | P | Note 1 | Notes 3, 5 | |||||
| Small Organ(See Note 2) | P | P | P | Note 1 | Notes 3, 5 | |||||
| Neonatal Cephalic | P | P | P | Note 1 | Notes 3, 5 | |||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral -Vascular | P | P | P | Note 1 | Note 5 | |||||
| Laparoscopic | ||||||||||
| Muscular-SkeletalConventional | P | P | P | Note 1 | Notes 3, 5 | |||||
| Muscular-SkeletalSuperficial | P | P | P | Note 1 | Notes 3, 5 | |||||
| Others(Specify) |
Mode of Oneration
N = new indication; P = previously cleared in K043455; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note 1: B/M, B/PVV Doppler
Note 2: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
Daniel H. Ingram
(Division Sian-O Division of Reproductive, Abdo and Radiological Device 510(k) Number
{7}------------------------------------------------
510(k) Number:
Device Name: L5-9EC for use with SONOACE X4
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler* | Power(Amp)Doppler | ColorVelocityImaging | Combined(Spec.) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | N | Note 1 | Notes 3, 5 | ||||
| Intra-Operative(See Note 4) | P | P | P | N | Note 1 | Notes 5 | ||||
| Intra-OperativeNeurological | ||||||||||
| Pediatric | P | P | P | N | Note 1 | Notes 3, 5 | ||||
| Small Organ(See Note 2) | P | P | P | N | Note 1 | Notes 3, 5 | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral -Vascular | P | P | P | N | Note 1 | Note 5 | ||||
| Laparoscopic | ||||||||||
| Muscular-SkeletalConventional | P | P | P | N | Note 1 | Notes 3, 5 | ||||
| Muscular-SkeletalSuperficial | P | P | P | N | Note 1 | Notes 3, 5 | ||||
| Others (Specify) |
Mode of Operation
N = new indication; P = previously cleared in K012887 ; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note 2: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for quidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
David R. Lynn
(Division Sion-Of Division of Reproductive, Abdomi and Radiological Devices 510(k) Number
{8}------------------------------------------------
510(k) Number:
Device Name: L5-9EE for use with SONOACE X4
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler* | Power(Amp)Doppler | ColorVelocityImaging | Combined(Spec.) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-Operative(See Note 4) | ||||||||||
| Intra-OperativeNeurological | ||||||||||
| Pediatric | P | P | P | Note 1 | Notes 3, 5 | |||||
| Small Organ(See Note 2) | P | P | P | Note 1 | Notes 3, 5 | |||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral -Vascular | P | P | P | Note 1 | Note 5 | |||||
| Laparoscopic | ||||||||||
| Muscular-SkeletalConventional | P | P | P | Note 1 | Notes 3, 5 | |||||
| Muscular-SkeletalSuperficial | P | P | P | Note 1 | Notes 3, 5 | |||||
| Others(Specify) |
Mode of Operation
N = new indication; P = previously cleared in K043455 ; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note 2: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
David h. Sungum
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
{9}------------------------------------------------
510(k) Number:
Device Name: C2-4ES for use with SONOACE X4
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler* | Power(Amp)Doppler | ColorVelocityImaging | Combined(Spec.) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | N | Note 1 | Note 5 | |||||
| Abdominal | P | P | N | Note 1 | Note 5 | |||||
| Intra-Operative(See Note 4) | P | P | N | Note 1 | Note 5 | |||||
| Intra-OperativeNeurological | ||||||||||
| Pediatric | P | P | N | Note 1 | Note 5 | |||||
| Small Organ(See Note 2) | P | P | N | Note 1 | Note 5 | |||||
| Neonatal Cephalic | P | P | N | Note 1 | Note 5 | |||||
| Adult Cephalic | P | P | N | Note 1 | Note 5 | |||||
| Cardiac | P | P | N | Note 1 | Note 5 | |||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral -Vascular | P | P | N | Note 1 | Note 5 | |||||
| Laparoscopic | ||||||||||
| Muscular-SkeletalConventional | ||||||||||
| Muscular-SkeletalSuperficial | ||||||||||
| Others(Specify) |
Modo nf Anarating
N = new indication; P = previously cleared in K012887 ; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note 1: Dhi, Dr. V. Doppier
Note 2: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
David A. Johnson
(Division Sign-Off) Division of Reproductive. Abdomin and Radiological Devices 510(k) Number
{10}------------------------------------------------
510(k) Number:
Device Name: C2-5ET for use with SONOACE X4
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler* | Power(Amp)Doppler | ColorVelocityImaging | Combined(Spec.) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | Note 1 | Note 5 | |||||
| Abdominal | P | P | P | Note 1 | Note 5 | |||||
| Intra-Operative(See Note 4) | ||||||||||
| Intra-OperativeNeurological | ||||||||||
| Pediatric | N | N | N | Note 1 | Note 5 | |||||
| Small Organ(See Note 2) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral - Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Muscular-SkeletalConventional | ||||||||||
| Muscular-SkeletalSuperficial | ||||||||||
| Others(Specify) |
Mode of Oneration
N = new indication; P = previously cleared in K043455; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note 1. Diw, Dr. V. Doppic.
Note 2: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
Daniel H. Leyton
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number _
{11}------------------------------------------------
510(k) Number:
Device Name: C3-7ED for use with SONOACE X4
Device Name: "Oo read imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler* | Power(Amp)Doppler | ColorVelocityImaging | Combined(Spec.) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | Note 1 | Notes 3, 5, 6 | |||||
| Abdominal | P | P | P | Note 1 | Notes 3, 5, 6 | |||||
| Intra-Operative(See Note 4) | P | P | N | Note 1 | Notes 5, 6 | |||||
| Intra-OperativeNeurological | ||||||||||
| Pediatric | P | P | P | Note 1 | Notes 3, 5, 6 | |||||
| Small Organ(See Note 2) | P | P | N | Note 1 | Notes 3, 5, 6 | |||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral -Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Muscular-SkeletalConventional | P | P | N | Note 1 | Notes 3, 5, 6 | |||||
| Muscular-SkeletalSuperficial | P | P | N | Note 1 | Notes 3, 5, 6 | |||||
| Others(Specify) |
Mode of Oneration
N = new indication; P = previously cleared in K012887 & K043455 ; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note 1. Diw, Dri VV Dopper
Note 2: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
David R. Symm
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{12}------------------------------------------------
510(k) Number:
Device Name: C4-9ED for use with SONOACE X4
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler* | Power(Amp)Doppler | ColorVelocityImaging | Combined(Spec.) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | P | P | P | Note 1 | Notes 3, 5 | |||||
| Abdominal | ||||||||||
| Intra-Operative | ||||||||||
| (See Note 4) | ||||||||||
| Intra-OperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(See Note 2) | P | P | P | Note 1 | Notes 3, 5 | |||||
| Neonatal Cephalic | P | P | P | Note 1 | Notes 5 | |||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | P | P | P | Note 1 | Notes 3, 5 | |||||
| Trans-Vaginal | P | P | P | Note 1 | Notes 3, 5 | |||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral - Vascular | P | P | P | Note 1 | Notes 3, 5 | |||||
| Laparoscopic | ||||||||||
| Muscular-SkeletalConventional | ||||||||||
| Muscular-SkeletalSuperficial | ||||||||||
| Others(Specify) |
Mode of Operation
N = new indication; P = previously cleared in K043455; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note 1. BM, and W Dopplic patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
David K. Ingram
(Division Sian-Off) Division of Reproductive, Abd and Radiological Devices 510(k) Numbe
Prescription Use (Per 21 CFR 801.109)
Section 4.3, Page 8
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510(k) Number:
Device Name: EC4-9ED for use with SONOACE X4
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler* | Power(Amp)Doppler | ColorVelocityImaging | Combined(Spec.) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | Note 1 | Notes 3, 5 | |||||
| Abdominal | ||||||||||
| Intra-Operative(See Note 4) | ||||||||||
| Intra-OperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(See Note 2) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | P | P | P | Note 1 | Notes 3, 5 | |||||
| Trans-Vaginal | P | P | P | Note 1 | Notes 3, 5 | |||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral-Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Muscular-SkeletalConventional | ||||||||||
| Muscular-SkeletalSuperficial | ||||||||||
| Others (Specify) |
Mode of Operation
N = new indication; P = previously cleared in K043455; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note 2: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
David R. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
{14}------------------------------------------------
510(k) Number:
510(K) Nambor:
Device Name: EC4-9ES for use with SONOACE X4
Device Name: "EO4-5ES for ass w rated with thow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler* | Power(Amp)Doppler | ColorVelocityImaging | Combined(Spec.) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | P | P | P | Note 1 | Notes 3, 5 | |||||
| Abdominal | P | P | P | Note 1 | Notes 3, 5 | |||||
| Intra-Operative(See Note 4) | P | P | P | Note 1 | Notes 3, 5 | |||||
| Intra-OperativeNeurological | ||||||||||
| Pediatric | P | P | P | Note 1 | Notes 3, 5 | |||||
| Small Organ(See Note 2) | P | P | P | Note 1 | Notes 3, 5 | |||||
| Neonatal Cephalic | P | P | P | Note 1 | Notes 5 | |||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | P | P | P | Note 1 | Notes 3, 5 | |||||
| Trans-Vaginal | P | P | P | Note 1 | Notes 3, 5 | |||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral -Vascular | P | P | P | Note 1 | Notes 3, 5 | |||||
| Laparoscopic | ||||||||||
| Muscular-SkeletalConventional | P | P | P | Note 1 | Notes 3, 5 | |||||
| Muscular-SkeletalSuperficial | P | P | P | Note 1 | Notes 3, 5 | |||||
| Others(Specify) |
Mode of Operation
N = new indication; P = previously cleared in K012887; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note T. B/W, B/F W Doppler
Note 2: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
Daniel R. Leyton
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _
§ 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.