OMNIA X/XS ULTRASOUND SYSTEM
Device Facts
| Record ID | K020353 |
|---|---|
| Device Name | OMNIA X/XS ULTRASOUND SYSTEM |
| Applicant | Siemens Medical Systems, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Feb 13, 2002 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
The Omnia X/XS ultrasound imaging system is intended for the following applications: General, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neurology, Abdominal, Intraoperative, Gular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis. The system also provides information that is used for clinical diagnosis purposes.
Device Story
Omnia X/XS is a mobile, software-controlled diagnostic ultrasound system. It acquires primary or secondary harmonic ultrasound echo data via various transducers (convex, linear, phased sector, TEE). The system processes these signals to display images in B-Mode, M-Mode, Pulsed (PW) Doppler, Continuous (CW) Doppler, Color Doppler, Amplitude Doppler, Harmonic Imaging, or 3D imaging on a CRT display. It provides on-screen thermal and mechanical indices for bioeffect monitoring. Used in clinical settings by physicians or trained sonographers for anatomical measurement and fluid flow analysis to support clinical diagnosis. The system aids healthcare providers in visualizing internal structures and blood flow, facilitating diagnostic decision-making and patient management.
Clinical Evidence
Bench testing only. The device complies with safety standards including UL 2601-1, CSA C22.2 No. 601-1, and AIUM/NEMA standards for acoustic output measurement and real-time display of thermal and mechanical indices. Biocompatibility is verified per ISO 10993.
Technological Characteristics
Mobile diagnostic ultrasound system with CRT display. Supports multiple transducer types (convex, linear, phased, TEE). Connectivity includes on-screen display of thermal/mechanical indices. Software-controlled. Biocompatibility per ISO 10993. Safety compliance with UL 2601-1, CSA C22.2 No. 601-1, EN 60601-1 series, and IEC 1157.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, intraoperative (abdominal/neurological), pediatric, small organ (breast, testes, thyroid, penis, prostate), neonatal/adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, laparoscopic, and musculoskeletal (conventional/superficial) applications.
Regulatory Classification
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.
Predicate Devices
- SONOLINE Versa (K945773)
- SONOLINE Elegra (K902142, K002002, K96183, K981626, K980557, K981528, K001400)
Submission Summary (Full Text)
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FEB 1 3 2002
KU20553
Omnia X/XS Diagnostic Ultrasound System
510(k) Submission
#### 510(K) SUMMARY
## Omnia X/XS Diagnostic Ultrasound system
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance This Summaly of Salety and encercitose is promote as promote as provisions of a 510(k) Summary.
#### Submitted By: 1.
2.
Siemens Medical Solutions USA, Inc., Ultrasound Group 22010 S.E. 51st Street Issaquah, WA 98029
#### Contact Person:
Judi Hoffman Regulatory Affairs
Phone: (425) 557-1229 FAX: (425) 391-9198
Date Prepared: December 19, 2001
Proprietary Name: Omnia X/XS Ultrasound System
#### Common/ Usual Name:
Diagnostic Ultrasound System with Accessories
#### Classification Name:
21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System Ultrasonic Pulsed Echo Imaging System Diagnostic Ultrasound Transducer
FR # 892.1550 FR # 892.1560 FR # 892.1570 Product Code 90-IYN Product Code 90-IYO Product Code 90-ITX
#### 3. Predicate Device:
1 1945 773, 8/7/95, cleared as the Versa, marketed as the SONOLINE Versa/Versa Pro/Versa Plus/ Omnia with subsequent modifications.
1 165 Online Wared as Q4000, marketed as SONOLINE Elegra/Elegra Advances/Antares with subsequent modifications.
#### Device Description: বঁ
The Omnia X/XS is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging, or 3D imaging, on a CRT display.
The Omnia X/XS, has been designed to meet the following product safety standards:
- UL 2601-1, Safety Requirements for Medical Equipment 이
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment 에
- AIUM/NEMA, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic ■ Output Indices on Diagnostic Ultrasound Equipment
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- AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound 트
- 93/42/EEC Medical Devices Directive I
- Safety and EMC Requirements for Medical Equipment 1
- EN 60601-1 트
- EN 60601-1-1 체
- EN 60601-1-2
- IEC 1157 Declaration of Acoustic Power I
- ISO 10993 Biocompatibility ■
#### Intended Uses: 5.
The Omnia X/XS ultrasound imaging system is intended for the following applications: General The Ommal XIXO ultraoberative, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Kaulology, Abdominal, Intraoporative, Gular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides for the measurement of anatomical structures and for analysis THE System also provide information that is used for clinical diagnosis purposes.
#### Technological Comparison to Predicate Device: 6.
The Omnia X/XS is substantially equivalent to the SONOLINE Versa, cleared via K945773, and The Online XXC is substantially oquivalism to the some features of the SONOLNE Elegra, modified will K902142, K002002, and K96183, K981626, K980557, K981528 and K001400. All cleared the RS40072, and moulined into patients, then perform post processing of received systems than and and only the paratomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.
#### End of 510(k) Summary
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2002
Siemens Medical Solutions, USA % Mr. Mark Job TÜV Product Service, Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891
Re: K020353
Trade Name: SONOLINE Omnia X/XS Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYN and IYO Dated: February 1, 2002 Received: February 4, 2002
#### Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave ronowed your bour secure in edevice is substantially equivalent (for the itelevelocu above and we nave asselosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of the Amendinents, of to devices and in. Act (Act). You may, therefore, market the device, subject to I could I ood, Drug, and Cosmons of the Act. The general controls provisions of the Act include the general connois pro ristins of all 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 This decommiation of our of our min X/XS Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
C5-2 Convex Array C6-2 Convex Array C8-5 Convex Array 5.0C50+ Convex Array
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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 r &cturer states uiters guirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special beening including 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.
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The special report should reference the manufacturer's 510(k) number. It should be clearly and rne specificantly 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 I nis lotter will and in you wound substantial equivalence of your device to a legally marketed nouticate 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 11 you desire specific 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Jimit h. bymm
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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### Attachment 4
# Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
# SONOLINE Omnia X/XS (Versa Family) Ultrasound System
Device Name: Intended Use:
# Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 3D<br>Imaging |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC (P) | P | N |
| Abdominal | | P | P | P | P | P | P | | BMDC (P) | P | N |
| Intraoperative<br>Abdominal | | P | P | P | | P | P | | BMDC (P) | | N |
| Intraoperative<br>Neurological | | P | P | P | | P | P | | BMDC (P) | | N |
| Pediatric | | P | P | P | P | P | P | | BMDC (P) | P | N |
| Small Organ<br>(Specify)** | | P | P | P | P | P | P | | BMDC (P) | P | N |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC (P) | | N |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC (P) | P | |
| Cardiac | | P | P | P | P | P | P | | BMDC (P) | P | |
| Transesophageal | | P | P | P | | P | P | | BMDC (P) | N | N |
| Transrectal | | P | P | P | | P | P | | BMDC (P) | N | N |
| Transvaginal | | P | P | P | | P | P | | BMDC (P) | N | N |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC (P) | P | N |
| Laparoscopic | | P | P | P | | P | P | | BMDC (P) | | N |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | BMDC (P) | P | N |
| Musculo-skeletal<br>Superficial | | P | P | P | P | P | P | | BMDC (P) | N | N |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
** small organs (breast, testes, thyroid, penis, prostate)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Symm
cal De 510k) Numb
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510(k) Number (if known):
Device Name: Intended Use:
C5-2 Convex Array Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 3D<br>Imaging |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | E | E | E | | E | E | | BMDC (E) | E | |
| Abdominal | | E | E | E | | E | E | | BMDC (E) | E | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | E | E | E | | E | E | | BMDC (E) | E | |
| Small Organ<br>(Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | E | E | E | | E | E | | BMDC (E) | E | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial<br>Other (Specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Wegman
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices KC16353
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510(k) Number (if known):
Device Name: Intended Use:
C6-2 Convex Array Transducer for use with SONOLINE Omnia X/XS Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | | |
|---------------------------------------------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 3D<br>Imaging |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | BMDC (N) | N | N |
| Abdominal | | N | N | N | | N | N | | BMDC (N) | N | N |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | BMDC (N) | N | N |
| Small Organ<br>(Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | N | N | N | | N | N | | BMDC (N) | N | N |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional<br>Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Torin A. Seymore
(Division Sign-Off) Division of Reproductive, and Radiological Devic 510(k) Number
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### 510(k) Number (if known):
Device Name: Intended Use: C8-5 Convex Array Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 3D<br>Imaging |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | E | E | E | | E | E | | BMDC (E) | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | E | E | E | | E | E | | BMDC (E) | | N |
| Small Organ<br>(Specify)** | | N | N | N | | N | N | | BMDC (N) | | N |
| Neonatal Cephalic | | E | E | E | | E | E | | BMDC (E) | | N |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | N | | N | N | | BMDC (N) | | N |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Other (opodiy)
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments: _
** small organs (breast, testes, thyroid, penis, prostate)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Leggiero
(Division Sign-Off) Division of Reproductive, At and Radiological Devices 510(k) Number
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510(k) Number (if known):
5.0C50+ Convex Array Transducer for use with SONOLINE Omnia X/XS Device Name: Diagnostic imaging or fluid flow analysis of the human body as follows: Intended Use:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 3D<br>Imaging |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC (P) | | N |
| Abdominal | | P | P | P | P | P | P | | BMDC (P) | | N |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | E | E | E | E | E | E | | BMDC (E) | | N |
| Small Organ<br>(Specify)** | | E | E | E | E | E | E | | BMDC (E) | | N |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC (P) | | N |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
** small organs (breast, testes, thyroid, penis, prostate)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lyman
(Division Sign-Off) Division of Reproductive. A and Radiological Devices 510(k) Number
{10}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
C6-3 3D Mechanically driven 3D Convex Array Transducer for use with SONOLINE Omnia X/XS for use with OONOERYE Of the human body as follows:
Mode of Operation Color 3D Combined Harmonic Clinical Application Amplitude Color Velocity PWD CWD A B M Imaging Imaging (Specify) Doppler Doppler Imaging Ophthalmic N BMDC (N) N ાર N N N Fetal N BMDC (N) N N N N N Abdominal Intraoperative Abdominal Intraoperative Neurological N N BMDC (N) N N N N Pediatric Small Organ (Specify) Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify)
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Bergman
(Division Sign-Off) Division of Reproductive. Al and Radiological Devices 510(k) Number .
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510(k) Number (if known):
Device Name:
Intended Use:
EV9-4 Convex Array Endovaginal Transducer for use with SONOLINE Omnia X/XS lor use with SONOEINE Offinia 9070
Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation Color 3D Combined Amplitude Harmonic Clinical Application Color Velocity PWD CWD B Imaging M (Specify) Imaging A Doppler Doppler Imaging Ophthalmic N N BMDC (N) N ત્વ N N N Fetal Abdominal Intraoperative Abdominal Intraoperative Neurological Pediatric Small Organ (Specify) Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal N BMDC (N) N N N N N ನ Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify) N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Frant li. Bergman
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number .
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510(k) Number (if known):
Device Name:
Intended Use:
Endo-VII Mechanical Sector Endovaginal Transducer for use with SONOLINE Omnia X/XS Tor use with SONOEINE Offinia AJAO
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 3D<br>Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|---------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | BM (N) | | N |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | N | N | | | | | | BM (N) | | N |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | N |
| Transrectal | | N | N | | | | | | BM (N) | | N |
| Transvaginal | | N | N | | | | | | BM (N) | | N |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments: _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) P WRITE BEEON THIS Office of Device Evaluation (ODE)
Camid A. Lyman
(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number _
{13}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
Endo-V 3D Mechanical Sector Endovaginal Transducer for use with SONOLINE Omnia X/XS Tor use with SONOEINE Offinia 7070
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 3D<br>Imaging |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | BM (N) | | N |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | N | N | | | | | | BM (N) | | N |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by F
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Styrman
(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number _
{14}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
EC9-4 Convex Array Endovaginal Transducer for use with SONOLINE Omnia X/XS for use with SONOENYE Official ATAUltrasound imaging or fluid flow analysis of the human body as follows:
| | | | | | | Mode of Operation | | | | | |
|----------------------------------|---|---|---|-----|-----|-------------------|----------------------|------------------------------|-----------------------|---------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 3D<br>Imaging |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | BMDC (N) | N | N |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | N | N | N | | N | N | | BMDC (N) | N | N |
| Transvaginal | | N | N | N | | N | N | | BMDC (N) | N | N |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segner
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
{15}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use:
5.0L45 Linear Array Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 3D<br>Imaging |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | BMDC (N) | N | N |
| Abdominal | | N | N | N | N | N | N | | BMDC (N) | N | N |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify)** | | P | P | P | P | P | P | | BMDC (P) | P | N |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC (P) | P | N |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | BMDC (P) | P | N |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
** small organs (breast, testes, thyroid, penis, prostate)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Legron
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number __
{16}------------------------------------------------
#### 510(k) Number (if known):
Device Name: Intended Use:
7.5L70 Linear Array Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 3D<br>Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|---------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | BMDC (N) | | N |
| Small Organ<br>(Specify)** | | P | P | P | | P | P | | BMDC (P) | | N |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | E | E | E | | E | E | | BMDC (E) | | N |
| Musculo-skeletal<br>Superficial | | E | E | E | | E | E | | BMDC (E) | | N |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments: _
** small organs (breast, testes, thyroid, penis, prostate)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Hegemann
(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number _
{17}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use:
LB5-2 Linear Array Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 3D<br>Imaging |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | E | E | E | | E | E | | BMDC (E) | | |
| Abdominal | | E | E | E | | E | E | | BMDC (E) | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial<br>Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Hegeman
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{18}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use:
L10-5 Linear Array Transducer for use with SONOLINE Omnia X/XS E 10-5 Ellectif Array Transation of the human body as follows:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 3D<br>Imaging |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | N | N |
| Abdominal | | N | N | N | | N | N | | BMDC (N) | N | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | BMDC (N) | N | N |
| Pediatric | | N | N | N | | N | N | | BMDC (N) | N | N |
| Small Organ<br>(Specify) ** | | N | N | N | | N | N | | BMDC (N) | N | N |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | BMDC (N) | N | N |
| Peripheral vessel | | N | N | N | | N | N | | BMDC (N) | N | N |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | N | | N | N | | BMDC (N) | N | N |
| Musculo-skeletal<br>Superficial | | N | N | N | | N | N | | BMDC (N) | N | N |
| Other (specify) | | | | | | | | | | | |
Other (Spool))
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
** small organs (breast, testes, thyroid, penis, prostate)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) I WRITE BELOW TITAO ERE SON evice Evaluation (ODE)
David A. Segmen
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{19}------------------------------------------------
510(k) Number (if known):
VF13-5 Linear Array Transducer for use with SONOLINE Omnia X/XS Device Name: Diagnostic imaging or fluid flow analysis of the human body as follows: Intended Use:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 3D<br>Imaging |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | | BMDC (N) | | N |
| Small Organ<br>(Specify)** | | E | E | E | E | E | E | | BMDC (E) | | N |
| Neonatal Cephalic | | | | | |…
