(12 days)
Not Found
No
The document describes a standard digital ultrasound system with image processing features like smoothing and edge enhancement, which are common in medical imaging and do not inherently indicate AI/ML. There is no mention of AI, ML, deep learning, or any related concepts. The description focuses on the hardware and basic image processing capabilities.
No
The device is described as an "integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications," indicating its use for diagnosis, not therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." Additionally, the "Device Description" mentions the system is "capable of producing high detail resolution intended for clinical diagnostic imaging applications" and "to enhance the diagnostic utility and confidence provided by the system."
No
The device description explicitly states it is an "integrated preprogrammed color ultrasound imaging system" and mentions both portable and roll-around models, indicating it includes hardware components beyond just software.
No, 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 provided description clearly states that the SonoScape SSI-1000/SSI-5000 is an ultrasound imaging system. It uses sound waves to create images of internal structures of the human body.
- Intended Use: The intended use is for "Diagnostic ultrasound imaging or fluid flow analysis of the human body," which is a form of in vivo (within the living body) diagnostic imaging, not in vitro testing.
The device operates by interacting directly with the patient's body, not by analyzing samples taken from the body. Therefore, it falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
For SonoScape SSI-1000/SSI-5000 Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System:
Clinical Application: Abdominal (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Ob/GYN (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Pediatric (A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Small Organ (breast, thyroid, testes) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Cardiac (B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Transesophageal (A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Trans-Rectal (A, B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Trans-Vaginal (A, B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Peripheral Vascular (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Muscular-Skeletal Conventional (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined).
For 2P1, PA2.5 MHz Phased Array Diagnostic Ultrasound Transducer:
Clinical Application: Cardiac (A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined).
For L741, LA7.5 MHz Linear Array Diagnostic Ultrasound Transducer:
Clinical Application: Small Organ (breast, thyroid, testes) (A, B, M, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Peripheral Vascular (A, B, M, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Muscular-Skeletal Conventional (A, B, M, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined).
For C344, CLA3.5 MHz Curved Linear Array Diagnostic Ultrasound Transducer:
Clinical Application: Abdominal (A, B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Ob/GYN (A, B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined).
For MPTEE, 7-4MHz/10mm/64 element Multi-Plane Transesophageal Phased Array Diagnostic Ultrasound Transducer:
Clinical Application: Transesophageal (A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined).
For 5P1, 7-4MHz/10mm/64 element Phased Array Diagnostic Ultrasound Transducer:
Clinical Application: Pediatric (B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Cardiac (B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined).
For C611, 8-4MHz/R11mm/128 element Micro-convex Array Diagnostic Ultrasound Transducer:
Clinical Application: Pediatric (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Cardiac (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined).
For 6V1, 8-4MHz/R11mm/128 element Transvaginal Micro-convex Array Diagnostic Ultrasound Transducer:
Clinical Application: Ob/GYN (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Trans-Rectal (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Trans-Vaginal (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined).
For 10L1, 12-5MHz/38mm/128 element Flat Linear Array Diagnostic Ultrasound Transducer:
Clinical Application: Small Organ (breast, thyroid, testes) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Peripheral Vascular (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined); Muscular-Skeletal Conventional (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Tissue Harmonic Imaging, Combined).
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen; Pediatric; Small Organ (breast, thyroid, testes); soft tissue; Peripheral Vascular; Musculo-skeletal (conventional) and Urology.
Product codes
IYN, IYO, ITX
Device Description
The SonoScape SSI-1000/SSI-5000 ultrasound system is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations.
The SonoScape System can be configured either as a portable (SSI-1000) model, or as a roll-around model on wheels (SSI-5000).
Mentions image processing
Yes, "Image Processing: Smoothing, edge enhancement"
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
Abdomen; Pediatric; Small Organ (breast, thyroid, testes); soft tissue; Peripheral Vascular; Musculo-skeletal (conventional); Urology; Cardiac; Neurological (IntraOperative); Neonatal Cephalic; Adult Cephalic; Transesophageal; Trans-Rectal; Trans-Vaginal; Trans-Urethral; Intra-Vascular; Laparascopic; Obstetric; Gynecology.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physician.
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)
K042369, K970901, K991611, K010329
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing right, with flowing lines above and below them, representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 2005
SonoScape, Inc. % Mr. Bob Leiker Ouality & Regulatory Services 7263 Cronin Circle DUBLIN CA 94568
Re: K052042
،
.
Trade Name: SonoScape SSI-1000/SSI-5000TM
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560
Regulation Name: Ultrasonic pulsed echo imaging system . Regulation Number: 21 CFR 892.1570
Regulation Name: Diagnostic ultrasonic transducer . Regulatory Class: II
Product Code: IYN, IYO, and ITX
Dated: July 25, 2005
Received: July 28, 2005
Dear Mr. Leiker:
This letter corrects our substantially equivalent letter of August 9, 2005 regarding a wrong transducer number.
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 SonoScape SSI-1000/SSI-5000™, as described in your premarket notification:
Transducer Model Number
2P1, PA2.5 MHz Phased Array L741, LA7.5 MHz Linear Array
1
C344. CLA3.5 MHz Curved Linear Array MPTEE, 7-4 MHz/10mm/64 element Multi-Plane Transesophageal Phased Array 5P1. 7-4 MHz/10mm/64 element Phased Array C611. 8-4 MHz/R11mm/128 element Micro-convex Array 6V1, 8-4 MHz/R11mm/128 element Transvaginal Micro-convex Array 10L1, 12-5 MHz/38mm/128 element Flat Linear Array
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This 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
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David A. Leggett
fr
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
2
510(k) Number: __
Device Name: SonoScape SSI-1000/SSI-5000 Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined Tissue Harmonic Imaging |
| Opthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | Note 1 N | |||
| Ob/GYN | P | P | P | P | P | Note 1 N | |||
| IntraOperative | |||||||||
| Neurological | |||||||||
| Pediatric | N | N | N | N | N | N | Note 1 N | ||
| Small Organ (breast, thyroid, testes) | P | P | P | P | P | Note 1 N | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | P | P | P | P | P | P | Note 1 N | ||
| Transesophageal | N | N | N | N | N | N | Note 1 N | ||
| Trans-Rectal | N | N | N | N | N | Note 1 N | |||
| Trans-Vaginal | N | N | N | N | N | Note 1 N | |||
| Trans-Urethral | |||||||||
| Intra-Vascular | |||||||||
| Peripheral Vascular | P | P | P | P | P | Note 1 N | |||
| Laparascopic | |||||||||
| Muscular-Skeletal | |||||||||
| Conventional | P | P | P | P | P | Note 1 N | |||
| Muscular-Skeletal | |||||||||
| Superficial | |||||||||
| Others (Specify) |
P = previously cleared by FDA E = added under Appendix E N = new indication
Coabined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and Note 1: B/Power Doppler/PWD
Additional Comments:
Commissioner of CDRH, Office of Device Evaluation (ODE)
Nancy Chrogdon
Prescription Use (Per 21 CFR 801.109)
(Division Division ve, Abdominal, Indications F ge 2 of 10
3
510(k) Number: __
Device Name: 2P1, PA2.5 MHz Phased Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Hode of Oneration
| Clinical Application | Mode of Operation | | | | | | | | Tissue
Harmonic
Imaging | |
|------------------------------------------|-------------------|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------------|----------|
| | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | | Combined |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Ob/GYN | | | | | | | | | | |
| IntraOperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (breast,
thyroid, testes) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | | Note 1 | P |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |
P = previously cleared by FDA N = new indication E = added under Appendix E
Note 1: Combined includes: BM; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
Additional Comments:
CDRH. Office of Device Evaluation (OD)
Nancy Brogdon
(Division Sign-Off) Prescription Use (Per 21 CFR 801.109) Division of Reproductive and Radiological Devices 5 1 Officialistians For Use
4
510(k) Number: _
Device Name: L741, LA7.5 MHz Linear Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic uitrasound imaging or fluid flow analysis of the human body as follows: Mode of Oneration
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | Tissue | ||||||||
| Harmonic | ||||||||||
| Imaging | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Ob/GYN | ||||||||||
| IntraOperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (breast, | ||||||||||
| thyroid, testes) | P | P | P | P | P | Note 1 | P | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | Note 1 | P | |||
| Laparascopic | ||||||||||
| Muscular-Skeletal | ||||||||||
| Conventional | P | P | P | P | P | Note 1 | P | |||
| Muscular-Skeletal | ||||||||||
| Superficial | ||||||||||
| Others (Specify) |
P = previously cleared by FDA E = added under Appendix E N = new indication
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
Additional Comments:
ence of CDRH, Office of Device Evaluation (ODE)
Nancyebro
(Division Sign O
and Radiological 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Section 4.3
Indications For Use
Page 4 of 10
5
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: C344, CLA3.5 MHz Curved Linear Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Oneration
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | Tissue | ||||||||
| Harmonic | ||||||||||
| Imaging | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | Note 1 | P | ||
| Ob/GYN | P | P | P | P | P | P | Note 1 | P | ||
| IntraOperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (breast, | ||||||||||
| thyroid, testes) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparascopic | ||||||||||
| Muscular-Skeletal | ||||||||||
| Conventional | ||||||||||
| Muscular-Skeletal | ||||||||||
| Superficial | ||||||||||
| Others (Specify) |
N = new indication P = previously cleared by FDA E = added under Appendix E
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
Additional Comments:
or of CDRA Ortion of Deveror & valuation (ODE)
Nancy C. Brogdon
Division Sign-Off)
(Division Sign Division of Reproduc and Partino at Indications For Use it Her
Prescription Use (Per 21 CFR 801.109) Section 4.3
age 5 of 10
6
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: MPTEE, 7-4MHz/10mm/64 element Multi-Plane Transesophageal Phased Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | Tissue | ||||||||
| Harmonic | ||||||||||
| Imaging | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Ob/GYN | ||||||||||
| IntraOperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (breast, | ||||||||||
| thyroid, testes) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | N | N | N | N | N | N | N | Note 1 | N | |
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparascopic | ||||||||||
| Muscular-Skeletal | ||||||||||
| Conventional | ||||||||||
| Muscular-Skeletal | ||||||||||
| Superficial | ||||||||||
| Others (Specify) |
N = new indication P = previously cleared by FDA E = added under Appendix E
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
Additional Comments:
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive. Abdominal,
and Radiological Devices
510(k) Number K052042
Prescription Use (Per 21 CFR 801.109)
Section 4.3
Indications For Use
Page 6 of 10
7
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: 5P1, 7-4MHz/10mm/64 element Phased Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | Tissue | ||||||||
| Harmonic | ||||||||||
| Imaging | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Ob/GYN | ||||||||||
| IntraOperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N | Note 1 | N | ||
| Small Organ (breast, | ||||||||||
| thyroid, testes) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | N | Note 1 | N | ||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparascopic | ||||||||||
| Muscular-Skeletal | ||||||||||
| Conventional | ||||||||||
| Muscular-Skeletal | ||||||||||
| Superficial | ||||||||||
| Others (Specify) |
N = new indication P = previously cleared by FDA E = added under Appendix E
Note 1: Combined includes: BM; BPWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
Additional Comments:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc Broglon
(Division Sign Off)
Division of Repro clive. Altominal, and Radiological Device Indications of on thember Page 7 of 10
Prescription Use (Per 21 CFR 801.109)
8
510(k) Number: __
Device Name: C611, 8-4MHz/R11mm/128 element Micro-convex Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Oneration
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | Tissue | ||||||||
| Harmonic | ||||||||||
| Imaging | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Ob/GYN | ||||||||||
| IntraOperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | N | N | N | N | N | Note 1 | N | |||
| Small Organ (breast, | ||||||||||
| thyroid, testes) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | Note 1 | N | |||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparascopic | ||||||||||
| Muscular-Skeletal | ||||||||||
| Conventional | ||||||||||
| Muscular-Skeletal | ||||||||||
| Superficial | ||||||||||
| Others (Specify) |
P = previously cleared by FDA N = new indication E = added under Appendix E
Note I: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
Additional Comments:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc bogdon
(Division Sign-Off)
Division of Repro Abd minal and Radiological De Indications FREFFAFA imber of 10
Prescription Use (Per 21 CFR 801.109)
9
510(k) Number: _
Device Name: 6V1, 8-4MHz/R11mm/128 element Transvaginal Micro-convex Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | Tissue | ||||||||
| Harmonic | ||||||||||
| Imaging | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Ob/GYN | N | N | N | N | N | Note 1 | N | |||
| IntraOperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (breast, | ||||||||||
| thyroid, testes) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | N | N | N | N | N | Note 1 | N | |||
| Trans-Vaginal | N | N | N | N | N | Note 1 | N | |||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparascopic | ||||||||||
| Muscular-Skeletal | ||||||||||
| Conventional | ||||||||||
| Muscular-Skeletal | ||||||||||
| Superficial | ||||||||||
| Others (Specify) |
N = new indication P = previously cleared by FDA E = added under Appendix E
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
Additional Comments:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Prescription Use (Per 21 CFR 801.109)
Division of Reproductive, Abdominal, and Radiological Devic Indications: Egytis finder Page 9 of 10
10
510(k) Number: K052042
Device Name: 10L1, 12-5MHz/38mm/128 element Flat Linear Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined | Tissue
Harmonic
Imaging |
|------------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|----------|-------------------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Ob/GYN | | | | | | | | | | |
| IntraOperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (breast,
thyroid, testes) | | N | N | N | | N | N | | Note 1 | N |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | Note 1 | N |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | N | N | N | | N | N | | Note 1 | N |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |
P = previously cleared by FDA E = added under Appendix E N = new indication
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
Additional Comments:
f CPRER, Office of Devic
currence of CDRH, Office of Device Evaluation (ODE)
Indications For Use
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
Prescription Use (Per 21 CFR 801.109)
ised Page 10 of 10
11
AUG 9 - 2005
PREMARKET NOTIFICATION [510(k)] Sum
- SonoScape Ultrasound System, SSI-1000/SSI-5000™ with 6V1 Trade Name: Micro-convex EndoCavity Linear Array, 10L1 Linear Array, MPTEE Multi-plane Trans-Esophageal Phased Array, 5P1 Phased Array, and C611 Micro-Convex Linear Array transducers.
- Diagnostic Ultrasound System and Transducers Common Name:
- Classification Names: Ultrasonic Pulsed Echo Imaging System, 90 IYO Ultrasonic Pulsed Doppler Imaging System, 90 IYN Diagnostic Ultrasound Transducer, 90 ITX
Manufacturer's Name: SonoScape Company Limited
4/F. Yizhe Building, Yuquan Road,
Nanshan, 518051, Shenzhen, China
- Mr. Jinzhong Yao, President Contact:
Telephone: (86) 755-26722890
Fax: (86) 755-26722850
- Bob Leiker U.S. Agent: Quality & Regulatory Services, Inc. Dublin, CA 94568
- SonoScape SSI-1000/SSI-5000, K042369 and the GE LogiQ 500, Predicate Devices: K970901, K991611, and K010329
The SonoScape SSI-1000/SSI-5000 ultrasound system is an Device Description: integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations.
The SonoScape System can be configured either as a portable (SSI-1000) model, or as a roll-around model on wheels (SSI-5000).
Attachment O
Premarket Notification 510(k) Summary
12
Intended Use: The device is a general-purpose ultrasonic imaging instrument intended for The device is a general purpose raluation of Abdomen; Pediatric; Small Organ ( use by a qualifica physician rooft tissue; Peripheral Vascular, Musculo-skeletal (conventional) and Urology.
Technological Characteristics
| Display Modes | Single and dual 2-D; Display of Duplex 2-D/M-mode; 2-D/Pulsed Doppler and
Triplex 2-D/CD/Pulsed Doppler image formats; Dual B and Color in real time |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurements | Distance; area; circumference; calipers; velocity, PI, RI. Cardiac. OB and Vascular
package |
| Principle of
Operation | Applying high voltage burst to the Piezoelectric material in the transducer and
detect the reflected echo to construct the 2-D B-mode, Doppler color, and Doppler
spectrum image for diagnostic purpose. |
| Operating
Controls | TGC 8 slider, +/- 24dB Depth Range: 3 to 24 cm Image sector size: 32 lines to full B (256 lines) Image Sector position: Steering within full maximum B orientation flip: L/R key with marking on the screen B Dynamic range control: preset 5 curves over 50-90 dB Gray Scale Control: 8 Settings Focal Number: 16 focal zone setting B persistence: 30-90% recursive Image Processing: Smoothing, edge enhancement PW sweeping speed 2,4,8 sec over display. PW Wall filter setting: 16 settings, 0.25 to 20% of PRF PW sample volume: 0.5 to 10mm with 0.5mm step size. PW/B update: with UPDATE key PW cursor steering: Steer soft key PW angle correction: 0 to 70 degree user control PW trace: Peak, Mean PW spectrum dynamic range: 5 preset curve over 15-48 dB Spectrum baseline shift and invert Color ROI setting: trackball and set key to control size and position Color steering on flat probe: +, 0, - Color Wall Filter: Color wall filter with 16 selection, 0.25-20% of PRF Color & B priority: C-B priority soft menu Color Packet size: preset per Exam range from 8 to 12 Color spatial filter: preset per Exam, horizontal, vertical, off Zoom factor: 1 to 10 continuously Cine control: step, play backward, play continuously |
| Acoustic
Output | Track 3; MI, TIS, TIC, TIB
Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical
Index: 1.9 Maximum, or Derated Isppa: 190 W/cm2 max |
| Display
Annotations | Time/date/year; transducer type; power output in %; frames per second;
persistence; and compression settings; image depth; patient name and ID;
institution name; focal position; TGC curve display; Doppler & M scale in sec;
Doppler angle correction cursor; EKG trace; probe tip temperature / angle for
MPTEE; free form annotation anywhere on image; trackball controlled; selective on
global erase of the display annotations, body markers with transducer annotations |
| Safety
Compliance | IEC601-1 International Electrotechnical Commission; Medical Electrical Equipment
IEC60601-2 International Electrotechnical Commission; Electromagnetic
Compatibility |