(13 days)
Not Found
No
The description focuses on conventional ultrasound technology, digital beamforming, and image processing techniques without mentioning AI or ML.
No.
The device is described as an ultrasound imaging system intended for diagnostic purposes, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body."
No
The device description explicitly details a cart-mounted console containing hardware components like an ultrasound generator/receiver, and mentions the use of various transducers and probes, indicating it is a hardware-based ultrasound system with accompanying software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an ultrasound imaging system. It uses sound waves to create images of internal structures of the human body.
- Intended Use: The intended use describes diagnostic ultrasound imaging and fluid flow analysis of the human body. This involves direct interaction with the patient's body, not the analysis of samples taken from the body.
- No Mention of Sample Analysis: There is no mention of analyzing biological samples or performing tests on substances outside of the body.
Therefore, the SonoAce SA-9900 is a medical imaging device, specifically an ultrasound system, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
- Fetal OB/GYN.
- Abdominal.
- Small Organs (breast, thyroid, testicle).
- Pediatric.
- Neonatal Cephalic.
- Trans-Vaginal.
- Trans-Rectal.
- Peripheral Vascular.
- Cardiac.
Typical examinations performed using the system are:
- General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies.
- Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall.
- Pediatric scans of organs, superficial, and bony structures.
- Monitoring procedures for infertility studies (other than in vitro fertilization).
- First, second and third trimester pregnancy studies.
- Neonatal head studies.
- Podiatry scans of superficial structures including muscles, tendons and bones.
- General cardiac studies in adults.
- Prostate, bladder and rectum visualization.
Product codes (comma separated list FDA assigned to the subject device)
90-IYO, 90-ITX
Device Description
The SonoAce SA-9900 scanner is a multiple-mode, multiple-application ultrasound imaging system. The cart-mounted console contains an ultrasound generator/receiver offering a full complement of conventional operating modes, software-based parameter controls, and recording. The selection of eight transducers to be offered with the system permits a wide range of clinical applications. The various transducers adapt the system for the specific imaging tasks.
Eight different models of transducers are available. In addition to the initial operational settings for each transducer preprogrammed in the system, user customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. Patient contact materials have been tested for biocompatibility in accordance to their intended use and are used for each individual transducer.
The SonoAce SA-9900 uses digital beamforming technology. The SonoAce SA-9900 supports a variety of Linear and Convex probes for wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. The SonoAce SA-9900 provides high quality images and various measuring functions. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of the SonoAce SA-9900 are B-Mode, M-Mode, Tissue Harmonic Imaging (THI), Color-flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Small Organs (breast, thyroid, testicle), Pediatric, Neonatal Cephalic, Trans-Vaginal, Trans-Rectal, Peripheral Vascular, Cardiac, Muscular-Skeletal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K940942, K992155, K974269, K990970, K992470
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
510(k) Premarket Notification
AUG - 1 2000
2185
SA - 9900 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.
- Submitter's name, address, telephone number, contact person: 1) Regulatory Management Services 16303 Panoramic Way San Leandro, CA 94578-1116 Gary J. Allsebrook Regulatory Affairs Consultant (510) 276-2648 Telephone: (510) 276-3559 Fax: regman1@home.com Email June 19, 2000 Prepared
- Name of the device, including the trade or proprietary name if 2) applicable, the common or usual name, and the classification name, if known:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
SA - 9900 Diagnostic Ultrasound System and Transducers.
Classification Names:
| FR Number | Product Code | |
|---|---|---|
| Ultrasound Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
1
Identification of the predicate or legally marketed device: 3)
Medison America, Inc believes that SA-9900 Ultrasound system is substantially equivalent to the currently marketed Medison/Kretztechnik Combison 530D (K940942 & K992155), SonoAce SA-8800 (K974269) and SonoAce 6000C/Ultramark 400C (K990970 & K992470) .
4) Device Description:
SonoAce SA-9900:
The SonoAce SA-9900 scanner is a multiple-mode, multiple-application ultrasound imaging system. The cart-mounted console contains an ultrasound generator/receiver offering a full complement of conventional operating modes, software-based parameter controls, and recording. The selection of eight transducers to be offered with the system permits a wide range of clinical applications. The various transducers adapt the system for the specific imaging tasks.
Eight different models of transducers are available. In addition to the initial operational settings for each transducer preprogrammed in the system, usercustomized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. Patient contact materials have been tested for biocompatibility in accordance to their intended use and are used for each individual transducer.
The SonoAce SA-9900 uses digital beamforming technology. The SonoAce SA-9900 supports a variety of Linear and Convex probes for wide variety of applications. It is an ultrasound scanner, which provides high resolution, high
2
penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. The SonoAce SA-9900 provides high quality images and various measuring functions. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of the SonoAce SA-9900 are B-Mode, M-Mode, Tissue Harmonic Imaging (THI), Color-flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The same clinical uses were cleared for the predicate device(s), Medison/Kretztechnik Combison 530D (K940942 & K992155), SonoAce SA-8800 (K974269) and SonoAce 6000C/Ultramark 400C (K990970 & K992470) .
5) Intended Use:
- Fetal OB/GYN .
- Abdominal .
- . Small Organs (breast, thyroid, testicle)
- Pediatric .
- Neonatal Cephalic .
- Trans-Vaginal .
- . Trans-Rectal
- Peripheral Vascular .
- Cardiac .
Typical examinations performed using the system are:
- . General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies.
- Study of small parts and superficial structures including breasts, shoulders, . thyroid, and the abdominal wall.
3
- . Pediatric scans of organs, superficial, and bony structures.
- Monitoring procedures for infertility studies (other than in vitro fertilization).
- . First, second and third trimester pregnancy studies.
- . Neonatal head studies.
- . Podiatry scans of superficial structures including muscles, tendons and bones.
- . General cardiac studies in adults.
- . Prostate, bladder and rectum visualization.
6) Technological Characteristics:
This device operates identical to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as a 2D and M-mode images. Scanhead patient contact materials are biocompatible.
The device's acoustic output limits are:
All Applications:
| ISPTAd | 720 mW/cm2 (maximum) | |
|---|---|---|
| TIS/TIB/TIC | 0.0 - 5.0 | (Range) |
| MI | 1.9 | (Maximum) |
The limits are the same as predicate Track 3 devices.
4
Image /page/4/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird or eagle with its wings spread.
1 2000 AUG
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medison America, Inc. c/o Carole Stamp TUV Product Service 1775 Old Highway 8, NW, Suite 104 New Brighton, MN 55112-1891
Re: K002185
Sonoace SA - 9900 Diagnostic Ultrasound System Regulatory Class: II 21CFR 892.1550/Procode: 90 IYN 21CFR 892.1560/Procode: 90 IYO 21CFR 892.1570/Procode: 90 ITX Dated: July 18, 2000 Received: July 19, 2000
Dear Ms. Stamp:
We have reviewed your Section 510(k) 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). 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 misbranion.
This determination of substantial equivalence applies to the following transducers intended for use with the Sonoace SA - 9900 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
EC4-9ES, Curved Linear Array 6.5 MHz/10R/140D L5-121R, Linear Array 7.5 MHz/40mm/192 elements C2-51R, Curved Linear Array 3.5 MHz/40R/85D P2-5AC, Phased Array 3.5 MHz P3-7AC, Phased Array 4.5 MHz 2.0CW, Static CW 2.0 MHz S-VAW3-5, Volume Curved Array 3.5 MHz S-VAW4-7, Volume Curved Array 4.5 MHz S-VDW5-8, Volume Curved Array 6.5 MHz
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page -2- Ms. Carole Stamp
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally; for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Paul M. Gammell, Ph. D. at (301) 594-1212.
Sincerely yours,
Daniel A. Seymore
Daniel G. Schultz, M. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
6
Section 4.3 INDICATION FOR USE Ultrasound Device Indications Statement
510(k) Number:
Device Name: SonoAce 9900 Ultrasound System
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M* | PWD* | CWD | Color
Doppler* | Power
(Amp)
Doppler* | Combined
(Specify)* | Other
(Specify) |
|-----------------------------------|---|---|----|------|-----|-------------------|----------------------------|------------------------|--------------------|
| Ophthalmic | | | | | | | | | |
| Fetal (See Note 3) | N | N | N | N | | N | N | Note 1 | Note 2, 5, 6 |
| Abdominal | N | N | N | N | | N | N | Note 1 | Note 2, 5, 6 |
| Intra-Operative
(See Note 7) | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | Note 1 | Note 2, 5, 6 |
| Small Organ
(See Note 4) | N | N | N | N | | N | N | Note 1 | Note 2, 5 |
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1 | Note 5, 6 |
| Adult Cephalic | N | N | N | N | N | N | N | Note 1 | Note 5, 6 |
| Cardiac | N | N | N | N | N | N | N | Note 1 | Note 5, 6 |
| Transesophageal | | | | | | | | | |
| Trans-Rectal | N | N | N | N | | N | N | Note 1 | Note 2, 5 |
| Trans-Vaginal | N | N | N | N | | N | N | Note 1 | Note 2, 5 |
| Trans-Urethral | | | | | | | | | |
| Intra-Vascular | | | | | | | | | |
| Peripheral -Vascular | N | N | N | N | | N | N | Note 1 | Note 5 |
| Laparoscopic | | | | | | | | | |
| Muscular-Skeletal
Conventional | N | N | N | N | | N | N | Note 1 | Note 2, 5 |
| Muscular-Skeletal
Superficial | N | N | N | N | | N | N | Note 1 | Note 2, 5 |
| Others(Specify) | | | | | | | | | |
Mode of Operation (*includes simultaneous B-mode)
N = new indication; P = previously cleared in K990970, SA 6000C/ UM 400C system; E = added under Appendix E Other Indications or Modes
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
510(k) Number
Note 4: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Note 7: Abdominal organs and peripheral vessel
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Segner
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Devices
7
| 510(k) Number: | |
|---|---|
| Device Name: | SonoAce 9900 Ultrasound System |
| Transducer: | EC4-9ES, Curved Linear Array 6.5MHz/10R/140D |
| Indications for Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
Mode of Operation (*includes simultaneous B-mode)
| Color | Power | Combined | Other | |||
|---|---|---|---|---|---|---|
| -- | -- | -- | ------- | ------- | ---------- | ------- |
| Clinical Application | A | B | M* | PWD* | CWD | Color
Doppler* | Power
(Amp)
Doppler* | Combined
(Specify)* | Other
(Specify) | |
|-----------------------------------|---|---|----|------|-----|-------------------|----------------------------|------------------------|--------------------|--|
| Ophthalmic | | | | | | | | | | |
| Fetal (See Note 3) | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative
(See Note 7) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(See Note 4) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | N | N | N | | N | N | Note 1 | Note 2, 5 | |
| Trans-Vaginal | | N | N | N | | N | N | Note 1 | Note 2, 5 | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |
N = new indication; P = previously cleared in K990970, SA 6000C/ UM 400C system; E = added under Appendix E Other Indications or Modes
Note 1: PWD/Color Doppler, PWD/Power Doppler (N)
Note 2: Includes imaging for guidance of biopsy (N)
Note 3: Includes infertility monitoring of follicle development
Note 4: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 5: 3D Imaging (N)
Note 6: Harmonic Imaging
Note 7: Abdominal organs and peripheral vessel
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Daniel le. Seaman
(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological D
510(k) Number
8
510(k) Number:
SonoAce 9900 Ultrasound System Device Name:
L5-12IR. Linear Array 7.5MHz/40mm/192elements Transducer:
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M* | PWD* | CWD | Color
Doppler* | Power
(Amp)
Doppler* | Combined
(Specify)* | Other
(Specify) | |
|-----------------------------------|---|---|----|------|-----|-------------------|----------------------------|------------------------|--------------------|--|
| Ophthalmic | | | | | | | | | | |
| Fetal (See Note 3) | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative
(See Note 7) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | Note 1 | Note 2, 5 | |
| Small Organ
(See Note 5) | | N | N | N | | N | N | Note 1 | Note 2, 5 | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Peripheral -Vascular | | N | N | N | | N | N | Note 1 | Note 5 | |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | N | N | N | | N | N | Note 1 | Note 2, 5 | |
| Muscular-Skeletal
Superficial | | N | N | N | | N | N | Note 1 | Note 2, 5 | |
| Others(Specify) | | | | | | | | | | |
Mode of Operation (*includes simultaneous B-mode)
N = new indication; P = previously cleared in K990970, SA 6000C/ UM 400C system; E = added under Appendix E Other Indications or Modes
Note 1: PWD/Color Doppler, PWD/Power Doppler (N)
Note 2: Includes imaging for guidance of biopsy (N)
Note 3: Includes infertility monitoring of follicle development
Note 4: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 5: 3D Imaging (N)
Note 6: Tissue Harmonic Imaging
Note 7: Abdominal organs and peripheral vessel
Concurrence of CDRH, Office of Device Evaluation (ODE)
✓ Prescription Use (Per 21 CFR 801.109)
David A. Hegmann
(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological De
510(k) Number K002185
9
510(k) Number: SonoAce 9900 Ultrasound System Device Name: C2-5IR, Curved Linear Array 3.5MHz/40R/85D Transducer: Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M* | PWD* | CWD | Color
Doppler* | Power
(Amp)
Doppler* | Combined
(Specify)* | Other
(Specify) |
|-----------------------------------|---|---|----|------|-----|-------------------|----------------------------|------------------------|--------------------|
| Ophthalmic | | | | | | | | | |
| Fetal (See Note 3) | | N | N | N | | N | N | Note 1 | Note 2. 5. 6 |
| Abdominal | | N | N | N | | N | N | Note 1 | Note 2, 5, 6 |
| Intra-Operative
(See Note 7) | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | Note 1 | Note 2. 5. 6 |
| Small Organ
(See Note 4) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Transesophageal | | | | | | | | | |
| Trans-Rectal | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | |
| Trans-Urethral | | | | | | | | | |
| Intra-Vascular | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | |
| Others(Specify) | | | | | | | | | |
Mode of Operation (*includes simultaneous B-mode)
N = new indication; P = previously cleared in K990970, SA 6000C/ UM 400C system; E = added under Appendix E Other Indications or Modes
Note 1: PWD/Color Doppler, PWD/Power Doppler (N)
Note 2: Includes imaging for guidance of biopsy (N)
Note 3: Includes infertility monitoring of follicle development
Note 4: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 5: 3D Imaging (N)
Note 6: Tissue Harmonic Imaging (N)
Note 7: Abdominal organs and peripheral vessel
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Torid A. Hegson
(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, E and Radiological
10
510(k) Number:
SonoAce 9900 Ultrasound System Device Name:
Transducer: P2-5AC, Phased Array 3.5MHz
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation (*includes simultaneous B-mode)
| Clinical Application | A | B | M * | PWD* | CWD | Color
Doppler* | Power
(Amp)
Doppler* | Combined
(Specify)* | Other
(Specify) |
|-----------------------------------|---|---|-----|------|-----|-------------------|----------------------------|------------------------|--------------------|
| Ophthalmic | | | | | | | | | |
| Fetal (See Note 3) | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-Operative
(See Note 7) | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | Note 1 | Note 5. 6 |
| Small Organ
(See Note 4) | | | | | | | | | |
| Neonatal Cephalic | | N | N | N | N | N | N | Note 1 | Note 5, 6 |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | N | N | N | N | N | N | Note 1 | Note 5, 6 |
| Transesophageal | | | | | | | | | |
| Trans-Rectal | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | |
| Trans-Urethral | | | | | | | | | |
| Intra-Vascular | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | |
N = new indication; P = previously cleared in K990970, SA 6000C/ UM 400C system; E = added under Appendix E Other Indications or Modes
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (N) Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 5: 3D Imaging (N)
Note 6: Tissue Harmonic Imaging (N)
Note 7: Abdominal organs and peripheral vessel
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Daniel G. Legum
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K002183
11
| 510(k) Number: | |
|---|---|
| ---------------- | -- |
SonoAce 9900 Ultrasound System Device Name:
Transducer: P3-7AC, Phased Array 4.5MHz
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation (*includes simultaneous B-mode)
| Clinical Application | A | B | M* | PWD* | CWD | Color
Doppler* | Power
(Amp)
Doppler* | Combined
(Specify)* | Other
(Specify) | |
|-----------------------------------|---|---|----|------|-----|-------------------|----------------------------|------------------------|--------------------|--|
| Ophthalmic | | | | | | | | | | |
| Fetal (See Note 3) | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative
(See Note 7) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | Note 1 | Note 5, 6 | |
| Small Organ
(See Note 4) | | | | | | | | | | |
| Neonatal Cephalic | | N | N | N | N | N | N | Note 1 | Note 5, 6 | |
| Adult Cephalic | | N | N | N | N | N | N | Note 1 | Note 5, 6 | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |
N = new indication; P = previously cleared in K990970, SA 6000C/ UM 400C system; E = added under Appendix E Other Indications or Modes
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (N) Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
510(k) Number
Note 4: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 5: 3D Imaging (N)
Note 6: Tissue Harmonic Imaging (N)
Note 7: Abdominal organs and peripheral vessel
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Bet 21 CFR 801.109)
David C. Hanson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
Basic Information
12
| 510(k) Number: | |
|---|---|
| Device Name: | SonoAce 9900 Ultrasound System |
| Transducer: | 2.0CW, Static CW 2.0MHz |
| Indications for Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body |
as follows:
Mode of Operation (*includes simultaneous B-mode)
| Color | Power | Combined | Other | ||||
|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | ------- | ------- | ---------- | ------- |
| Clinical Application | A | B | M* | PWD* | CWD | Color
Doppler* | Power
(Amp)
Doppler* | Combined
(Specify)* | Other
(Specify) |
|-----------------------------------|---|---|----|------|-----|-------------------|----------------------------|------------------------|--------------------|
| Ophthalmic | | | | | | | | | |
| Fetal (See Note 3) | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-Operative
(See Note 7) | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | |
| Pediatric | | | | | N | | | | |
| Small Organ
(See Note 4) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | | | N | | | | |
| Transesophageal | | | | | | | | | |
| Trans-Rectal | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | |
| Trans-Urethral | | | | | | | | | |
| Intra-Vascular | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
N = new indication; P = previously cleared in K990970, SA 6000C/ UM 400C system; E = added under Appendix E Other Indications or Modes
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
510(k) Number
Note 4: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 5: 3D Imaging
Note 6: Tissue Harmonic Imaging
Note 7: Abdominal organs and peripheral vessel
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Prescription Use (Per 21 CFR 801.109)
David A. Lynn
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
13
510(k) Number:
SonoAce 9900 Ultrasound System Device Name:
S-VAW3-5, Volume Curved Array 3.5MHz Transducer:
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation (*includes simultaneous B-mode)
| Clinical Application | A | B | M* | PWD* | CWD | Color
Doppler* | Power
(Amp)
Doppler* | Combined
(Specify)* | Other
(Specify) |
|-----------------------------------|---|---|----|------|-----|-------------------|----------------------------|------------------------|--------------------|
| Ophthalmic | | | | | | | | | |
| Fetal (See Note 3) | E | E | E | E | | E | E | Note 1 | Note 2, 5, 6 |
| Abdominal | E | E | E | E | | E | E | Note 1 | Note 2. 5, 6 |
| Intra-Operative
(See Note 7) | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | |
| Pediatric | E | E | E | E | | E | E | Note 1 | Note 2, 5, 6 |
| Small Organ
(See Note 4) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Transesophageal | | | | | | | | | |
| Trans-Rectal | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | |
| Trans-Urethral | | | | | | | | | |
| Intra-Vascular | | | | | | | | | |
| Peripheral - Vascular | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | |
| Others(Specify) | | | | | | | | | |
N = new indication; P = previously cleared in K940942, Voluson C530D system; P = previously cleared in K974813, Voluson C530D Power Doppler mode; P2 = previously cleared in K993517, Voluson C530D Power Doppler mode; E = added under Appendix E
Other Indications or Modes
Note 1: PWD/Color Doppler, PWD/Power Doppler (E)
Note 2: Includes imaging for guidance of biopsy (E)
Note 3: Includes infertility monitoring of follicle development
Note 4: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 5: 3D Imaging (E)
Note 6: Tissue Harmonic Imaging (P2)
Note 7: Abdominal organs and peripheral vessel
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David h. leppon
(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devices
510(k) Number
Basic Information
14
510(k) Number:
SonoAce 9900 Ultrasound System Device Name:
S-VAW4-7, Volume Curved Array 4.5MHz Transducer:
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation (*includes simultaneous B-mode)
| Clinical Application | A | B | M* | PWD* | CWD | Color
Doppler* | Power
(Amp)
Doppler* | Combined
(Specify)* | Other
(Specify) |
|-----------------------------------|---|---|----|------|-----|-------------------|----------------------------|------------------------|--------------------|
| Ophthalmic | | | | | | | | | |
| Fetal (See Note 3) | | P | P | P | | P | P | Note 1 | Note 2, 5, 6 |
| Abdominal | | P | P | P | | P | P | Note 1 | Note 2, 5, 6 |
| Intra-Operative
(See Note 7) | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | |
| Pediatric | | P | P | P | | P | N | Note 1 | Note 2, 5, 6 |
| Small Organ
(See Note 4) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Transesophageal | | | | | | | | | |
| Trans-Rectal | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | |
| Trans-Urethral | | | | | | | | | |
| Intra-Vascular | | | | | | | | | |
| Peripheral - Vascular | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | |
| Others(Specify) | | | | | | | | | |
N = new indication; P = previously cleared in K992155, C530D Voluson system; P = previously cleared in K974813, Voluson C530D Power Doppler mode; P2 = previously cleared in K993517, Voluson C530D Power Doppler mode; E = added under Appendix E
Other Indications or Modes
Note 1: PWD/Color Doppler, PWD/Power Doppler (P)
Note 2: Includes imaging for guidance of biopsy (P)
Note 3: Includes infertility monitoring of follicle development
Note 4: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 5: 3D Imaging (P)
Note 6: Tissue Harmonic Imaging (P2)
Note 7: Abdominal organs and peripheral vessel
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 2PCFR 801.109)
David A. Lymm
(Division Sign-Off)
production of Reproductive, Abdominal, EN
Division of Reproductive, Abdominal, EN and Radiological Devices
510(k) Number
15
| Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body
as follows:
| Mode of Operation (*includes simultaneous B-mode) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M * | PWD* | CWD | Color | |||
| Doppler* | Power | ||||||||
| (Amp) | |||||||||
| Doppler* | Combined | ||||||||
| (Specify)* | Other | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal (See Note 3) | |||||||||
| Abdominal | |||||||||
| Intra-Operative | |||||||||
| (See Note 7) | |||||||||
| Intra-Operative | |||||||||
| Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| (See Note 4) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Trans-Rectal | E | E | E | E | E | E | Note 1 | Note 2, 5 | |
| Trans-Vaginal | E | E | E | E | E | E | Note 1 | Note 2, 5 | |
| Trans-Urethral | |||||||||
| Intra-Vascular | |||||||||
| Peripheral -Vascular | |||||||||
| Laparoscopic | |||||||||
| Muscular-Skeletal | |||||||||
| Conventional | |||||||||
| Muscular-Skeletal |
N = new indication; P = previously cleared in K940942, Voluson C530D system; P = previously cleared in K974813, Voluson C530D Power Doppler mode; E = added under Appendix E
Other Indications or Modes
Note 1: PWD/Color Doppler, PWD/Power Doppler (E)
Note 2: Includes imaging for guidance of biopsy (E)
Note 3: Includes infertility monitoring of follicle development
Note 4: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 5: 3D Imaging (E)
Note 5. 3D imaging (L)
Note 6. Tissue Handling
Note 6: Tissue Harmonic Imaging
Note 7: Abdominal organs and peripheral vessel
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR, 801.109)
Prescription Use (Per 21 CFR 801.109)
David A. Lipton
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Device
510(k) Number K002185