(9 days)
No
The provided text describes a standard diagnostic ultrasound system and does not mention any AI or ML capabilities.
No
The device is described as a "diagnostic ultrasound system" and its function is to "acquire primary or secondary harmonic ultrasound echo data and display it," which is for clinical diagnosis purposes, not for treatment.
Yes
The "Intended Use / Indications for Use" section states: "The system also provide information that is used for clinical diagnosis purposes." Additionally, the "Device Description" refers to it as a "diagnostic ultrasound system."
No
The device description explicitly states it is a "diagnostic ultrasound system," which inherently includes hardware components (transducer, processing unit, display) to acquire and display ultrasound data, even if it is software-controlled.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the system as an ultrasound imaging system for various anatomical applications. It acquires and displays ultrasound data for clinical diagnosis purposes. This is characteristic of an in vivo diagnostic device, which examines the body directly.
- Device Description: The description details a general purpose, mobile, software-controlled, diagnostic ultrasound system that acquires and displays ultrasound echo data in various modes. This aligns with the function of an in vivo ultrasound system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) outside of the body. IVD devices are specifically designed for testing these types of samples.
Therefore, the Omnia X/XS ultrasound imaging system, as described, is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Diagnostic imaging or fluid flow analysis of the human body as follows:
For SONOLINE Omnia X/XS (Versa Family) Ultrasound System:
Clinical Application and Mode of Operation:
Fetal: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), Harmonic Imaging (P)
Abdominal: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), Harmonic Imaging (P)
Intraoperative Abdominal: B (P), M (P), PWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P)
Intraoperative Neurological: B (P), M (P), PWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P)
Pediatric: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), Harmonic Imaging (P)
Small Organ (breast, testes, thyroid, penis, prostate): B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), Harmonic Imaging (P)
Neonatal Cephalic: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P)
Adult Cephalic: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), Harmonic Imaging (P)
Cardiac: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), Harmonic Imaging (P)
Transesophageal: B (P), M (P), PWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P)
Transrectal: B (P), M (P), PWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P)
Transvaginal: B (P), M (P), PWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P)
Peripheral vessel: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), Harmonic Imaging (P)
Laparoscopic: B (P), M (P), PWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P)
Musculo-skeletal Conventional: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), Harmonic Imaging (P)
Musculo-skeletal Superficial: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P)
For C5-2 Convex Array Transducer:
Clinical Application and Mode of Operation:
Fetal: B (E), M (E), PWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), Harmonic Imaging (E)
Abdominal: B (E), M (E), PWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), Harmonic Imaging (E)
Pediatric: B (E), M (E), PWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), Harmonic Imaging (E)
Peripheral vessel: B (E), M (E), PWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), Harmonic Imaging (E)
For C6-2 Convex Array Transducer:
Clinical Application and Mode of Operation:
Fetal: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Abdominal: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Pediatric: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Peripheral vessel: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
For C8-5 Convex Array Transducer:
Clinical Application and Mode of Operation:
Abdominal: B (E), M (E), PWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E)
Pediatric: B (E), M (E), PWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), 3D Imaging (N)
Small Organ (breast, testes, thyroid, penis, prostate): B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), 3D Imaging (N)
Neonatal Cephalic: B (E), M (E), PWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), 3D Imaging (N)
Musculo-skeletal Conventional: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), 3D Imaging (N)
For 5.0C50+ Convex Array Transducer:
Clinical Application and Mode of Operation:
Fetal: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), 3D Imaging (N)
Abdominal: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), 3D Imaging (N)
Pediatric: B (E), M (E), PWD (E), CWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), 3D Imaging (N)
Small Organ (breast, testes, thyroid, penis, prostate): B (E), M (E), PWD (E), CWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), 3D Imaging (N)
Peripheral vessel: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), 3D Imaging (N)
For C6-3 3D Mechanically driven 3D Convex Array Transducer:
Clinical Application and Mode of Operation:
Ophthalmic: A (N), B (N), M (N), PWD (N), CWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Fetal: A (N), B (N), M (N), PWD (N), CWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Abdominal: A (N), B (N), M (N), PWD (N), CWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Pediatric: A (N), B (N), M (N), PWD (N), CWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
For EV9-4 Convex Array Endovaginal Transducer:
Clinical Application and Mode of Operation:
Ophthalmic: A (N), B (N), M (N), PWD (N), CWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Fetal: A (N), B (N), M (N), PWD (N), CWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Abdominal: A (N), B (N), M (N), PWD (N), CWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Transrectal: A (N), B (N), M (N), PWD (N), CWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Transvaginal: A (N), B (N), M (N), PWD (N), CWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
For Endo-VII Mechanical Sector Endovaginal Transducer:
Clinical Application and Mode of Operation:
Fetal: B (N), M (N), Combined BM (N), 3D Imaging (N)
Neonatal Cephalic: B (N), M (N), Combined BM (N), 3D Imaging (N)
Transrectal: B (N), M (N), Combined BM (N), 3D Imaging (N)
Transvaginal: B (N), M (N), Combined BM (N), 3D Imaging (N)
For Endo-V 3D Mechanical Sector Endovaginal Transducer:
Clinical Application and Mode of Operation:
Fetal: B (N), M (N), Combined BM (N), 3D Imaging (N)
Transvaginal: B (N), M (N), Combined BM (N), 3D Imaging (N)
For EC9-4 Convex Array Endovaginal Transducer:
Clinical Application and Mode of Operation:
Fetal: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Transrectal: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Transvaginal: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
For 5.0L45 Linear Array Transducer:
Clinical Application and Mode of Operation:
Fetal: Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Abdominal: B (N), M (N), PWD (N), CWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Small Organ (breast, testes, thyroid, penis, prostate): B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), Harmonic Imaging (P), 3D Imaging (N)
Peripheral vessel: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), Harmonic Imaging (P), 3D Imaging (N)
Musculo-skeletal Conventional: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), Harmonic Imaging (P), 3D Imaging (N)
For 7.5L70 Linear Array Transducer:
Clinical Application and Mode of Operation:
Pediatric: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), 3D Imaging (N)
Small Organ (breast, testes, thyroid, penis, prostate): B (P), M (P), PWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), 3D Imaging (N)
Musculo-skeletal Conventional: B (E), M (E), PWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), 3D Imaging (N)
Musculo-skeletal Superficial: B (E), M (E), PWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), 3D Imaging (N)
For LB5-2 Linear Array Transducer:
Clinical Application and Mode of Operation:
Fetal: B (E), M (E), PWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E)
Abdominal: B (E), M (E), PWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E)
For L10-5 Linear Array Transducer:
Clinical Application and Mode of Operation:
Fetal: Harmonic Imaging (N), 3D Imaging (N)
Abdominal: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N)
Intraoperative Neurological: Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Pediatric: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Small Organ (breast, testes, thyroid, penis, prostate): B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Intravascular: Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Peripheral vessel: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Musculo-skeletal Conventional: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Musculo-skeletal Superficial: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
For VF13-5 Linear Array Transducer:
Clinical Application and Mode of Operation:
Pediatric: B (N), M (N), PWD (N), CWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), 3D Imaging (N)
Small Organ (breast, testes, thyroid, penis, prostate): B (E), M (E), PWD (E), CWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), 3D Imaging (N)
Peripheral vessel: B (E), M (E), PWD (E), CWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), 3D Imaging (N)
Musculo-skeletal Conventional: B (E), M (E), PWD (E), CWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), 3D Imaging (N)
Musculo-skeletal Superficial: B (E), M (E), PWD (E), CWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), 3D Imaging (N)
For VF13-5SP Linear Array Transducer:
Clinical Application and Mode of Operation:
Intraoperative Abdominal: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), 3D Imaging (N)
Intraoperative Neurological: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), 3D Imaging (N)
Pediatric: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), 3D Imaging (N)
Small Organ (breast, testes, thyroid, penis, prostate): B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), 3D Imaging (N)
Peripheral vessel: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), 3D Imaging (N)
Musculo-skeletal Conventional: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), 3D Imaging (N)
Musculo-skeletal Superficial: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), 3D Imaging (N)
For 7.5L50I Linear Array Transducer:
Clinical Application and Mode of Operation:
Abdominal: B (E), M (E), PWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), 3D Imaging (N)
Intraoperative Abdominal: B (P), M (P), PWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), 3D Imaging (N)
Small Organ (breast, testes, thyroid, penis, prostate): B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), 3D Imaging (N)
Peripheral vessel: B (E), M (E), PWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), 3D Imaging (N)
Musculo-skeletal Conventional: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), 3D Imaging (N)
For 7.5L50Q Linear Array Transducer:
Clinical Application and Mode of Operation:
Abdominal: B (P), M (P), PWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), 3D Imaging (N)
Intraoperative Abdominal: B (E), M (E), PWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), 3D Imaging (N)
Small Organ (breast, testes, thyroid, penis, prostate): B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), 3D Imaging (N)
Peripheral vessel: B (E), M (E), PWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), 3D Imaging (N)
Musculo-skeletal Conventional: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), 3D Imaging (N)
For LAP8-4 Laparoscopic Transducer:
Clinical Application and Mode of Operation:
Intraoperative Abdominal: B (P), M (P), PWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), 3D Imaging (N)
Laparoscopic: B (P), M (P), PWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P), 3D Imaging (N)
For P4-2 Phased Sector Array Transducer:
Clinical Application and Mode of Operation:
Abdominal: B (E), M (E), PWD (E), CWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), Harmonic Imaging (E)
Adult Cephalic: B (E), M (E), PWD (E), CWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), Harmonic Imaging (E)
Cardiac: B (E), M (E), PWD (E), CWD (E), Color Doppler (E), Amplitude Doppler (E), Combined BMDC (E), Harmonic Imaging (E)
For 5.0P10 Phased Sector Array Transducer:
Clinical Application and Mode of Operation:
Fetal: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P)
Abdominal: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P)
Pediatric: B (N), M (N), PWD (N), CWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N)
Neonatal Cephalic: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P)
Cardiac: B (P), M (P), PWD (P), CWD (P), Color Doppler (P), Amplitude Doppler (P), Combined BMDC (P)
For MPT7-4 Phased Sector Array TEE Transducer:
Clinical Application and Mode of Operation:
Trans-esophageal: B (N), M (N), PWD (N), Color Doppler (N), Amplitude Doppler (N), Combined BMDC (N), Harmonic Imaging (N), 3D Imaging (N)
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
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
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
AIUM/NEMA, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
93/42/EEC Medical Devices Directive
Safety and EMC Requirements for Medical Equipment
- EN 60601-1
- EN 60601-1-1
- EN 60601-1-2
IEC 1157 Declaration of Acoustic Power
ISO 10993 Biocompatibility
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
General, OB/GYN, Cardiac, Pelvic, Urology, Abdominal, Intraoperative, Vascular, Small Parts, Transcranial, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Fetal, Breast, Testes, Thyroid, Penis, Prostate, Neonatal Cephalic, Adult Cephalic, Transesophageal, Transrectal, Transvaginal, Intravascular.
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.
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.
K902142, K002002, K96183, K981626, K980557, K981528, K001400
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
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.
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
1
- 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
2
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
3
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 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.
4
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)
5
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| 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 | |||||||||||
| Abdominal | P | P | P | P | P | BMDC (P) | N | ||||
| Intraoperative | |||||||||||
| Neurological | P | P | P | P | P | BMDC (P) | N | ||||
| Pediatric | P | P | P | P | P | P | BMDC (P) | P | N | ||
| Small Organ | |||||||||||
| (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 | |||||||||||
| Conventional | P | P | P | P | P | P | BMDC (P) | P | N | ||
| Musculo-skeletal | |||||||||||
| 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
6
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | E | E | E | E | E | BMDC (E) | E | ||||
| Abdominal | E | E | E | E | E | BMDC (E) | E | ||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | E | E | E | E | E | BMDC (E) | E | ||||
| Small Organ | |||||||||||
| (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 | |||||||||||
| 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 C. Wegman
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices KC16353
7
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | BMDC (N) | N | N | |||
| Abdominal | N | N | N | N | N | BMDC (N) | N | N | |||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | N | N | N | N | N | BMDC (N) | N | N | |||
| Small Organ | |||||||||||
| (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 | |||||||||||
| 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)
Torin A. Seymore
(Division Sign-Off) Division of Reproductive, and Radiological Devic 510(k) Number
8
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | E | E | E | E | E | BMDC (E) | |||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | E | E | E | E | E | BMDC (E) | N | ||||
| Small Organ | |||||||||||
| (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 | |||||||||||
| Conventional | N | N | N | N | N | BMDC (N) | N | ||||
| Musculo-skeletal | |||||||||||
| 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
9
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P | BMDC (P) | N | |||
| Abdominal | P | P | P | P | P | P | BMDC (P) | N | |||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | E | E | E | E | E | E | BMDC (E) | N | |||
| Small Organ | |||||||||||
| (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 | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| 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 .
11
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 .
12
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
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging | 3D
Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|---------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | BM (N) | | N |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(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
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) 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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | N | N | BM (N) | N | |||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (Specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | N | N | BM (N) | N | |||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| 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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | BMDC (N) | N | N | |||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (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 | |||||||||||
| 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 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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | BMDC (N) | N | N | ||||||||
| Abdominal | N | N | N | N | N | N | BMDC (N) | N | N | ||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (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 | |||||||||||
| Conventional | P | P | P | P | P | P | BMDC (P) | P | N | ||
| Musculo-skeletal | |||||||||||
| 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
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging | 3D
Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|---------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | BMDC (N) | | N |
| Small Organ
(Specify)** | | P | P | P | | P | P | | BMDC (P) | | N |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | E | E | E | | E | E | | BMDC (E) | | N |
| Musculo-skeletal
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | E | E | E | E | E | BMDC (E) | |||||
| Abdominal | E | E | E | E | E | BMDC (E) | |||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (Specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| 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)
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | N | N | |||||||||
| Abdominal | N | N | N | N | N | BMDC (N) | N | ||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | BMDC (N) | N | N | ||||||||
| Pediatric | N | N | N | N | N | BMDC (N) | N | N | |||
| Small Organ | |||||||||||
| (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 | |||||||||||
| Conventional | N | N | N | N | N | BMDC (N) | N | N | |||
| Musculo-skeletal | |||||||||||
| 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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | N | N | N | N | N | N | BMDC (N) | N | |||
| Small Organ | |||||||||||
| (Specify)** | E | E | E | E | E | E | BMDC (E) | N | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | E | E | E | E | E | E | BMDC (E) | N | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | E | E | E | E | E | E | BMDC (E) | N | |||
| Musculo-skeletal | |||||||||||
| Superficial | E | 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. Segerson
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
20
510(k) Number (if known):
Device Name: Intended Use: VF13-5SP 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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | N | N | N | N | N | BMDC (N) | N | ||||
| Intraoperative | |||||||||||
| Neurological | N | N | N | N | N | BMDC (N) | N | ||||
| Pediatric | N | N | N | N | N | BMDC (N) | N | ||||
| Small Organ | |||||||||||
| (Specify)** | N | N | N | N | N | BMDC (N) | N | ||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | N | N | N | N | N | BMDC (N) | N | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | N | N | N | N | N | BMDC (N) | N | ||||
| Musculo-skeletal | |||||||||||
| Superficial | N | N | N | N | N | BMDC (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. Bergman
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
21
510(k) Number (if known):
Device Name: Intended Use: 7.5L50I 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 | ||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined | |||||||||||
| (Specify) | Harmonic | |||||||||||
| Imaging | 3D | |||||||||||
| Imaging | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | E | E | E | E | E | BMDC (E) | N | |||||
| Intraoperative | ||||||||||||
| Abdominal | P | P | P | P | P | BMDC (P) | N | |||||
| Intraoperative | ||||||||||||
| Neurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ | ||||||||||||
| (Specify) ** | N | N | N | N | N | BMDC (N) | N | |||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral vessel | E | E | E | E | E | BMDC (E) | N | |||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Conventional | N | N | N | N | N | BMDC (N) | N | |||||
| Musculo-skeletal | ||||||||||||
| 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. Bergman
(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number _
22
510(k) Number (if known):
Device Name: Intended Use:
7.5L50Q 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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | P | P | P | P | P | BMDC (P) | N | ||||
| Intraoperative | |||||||||||
| Abdominal | E | E | E | E | E | BMDC (E) | N | ||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (Specify) ** | N | N | N | N | N | BMDC (N) | N | ||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | E | E | E | E | E | BMDC (E) | N | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | N | N | N | N | N | BMDC (N) | N | ||||
| Musculo-skeletal | |||||||||||
| 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. Segerson
(Division Sign-Off) Dension of Reproductive, Abdomin od Radiological Devices a Pilid Number_
23
510(k) Number (if known):
Device Name: Intended Use:
LAP8-4 Laparoscopic 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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | P | P | P | P | P | BMDC (P) | N | ||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (Specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | P | P | P | P | P | BMDC (P) | N | ||||
| 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)
Elniel A. Segarra
(Division Sign-Off) Division of Reproductive, Abde and Radiological Devices
24
510(k) Number (if known):
Device Name: Intended Use:
P4-2 Phased Sector 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 | ||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined | |||||||||||
| (Specify) | Harmonic | |||||||||||
| Imaging | 3D | |||||||||||
| Imaging | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | E | E | E | E | E | E | BMDC (E) | E | ||||
| Intraoperative | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative | ||||||||||||
| Neurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ | ||||||||||||
| (Specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | E | E | E | E | E | E | BMDC (E) | E | ||||
| Cardiac | E | E | E | E | E | E | BMDC (E) | E | ||||
| Transesophageal | ||||||||||||
| 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 A. Segura
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _
25
510(k) Number (if known):
Device Name: Intended Use:
5.0P10 Phased Sector 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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P | BMDC (P) | ||||
| Abdominal | P | P | P | P | P | P | BMDC (P) | ||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | N | N | N | N | N | N | BMDC (N) | ||||
| Small Organ | |||||||||||
| (Specify) | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | BMDC (P) | ||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | BMDC (P) | ||||
| Transesophageal | |||||||||||
| 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 M. Severson
(Division Sign-Off) Division of Reproductive, Abdor and Radiological Devices + 10(k) Number _______________________________________________________________________________________________________________________________________________________________
26
510(k) Number (if known):
Device Name:
Intended Use:
MPT7-4 Phased Sector Array TEE 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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | 3D | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (Specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | N | N | N | N | N | BMDC (N) | N | N | |||
| 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)
Prescription Use (Per 21 CFR 801.109)
David A. Hegmann
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
12/19/01