(274 days)
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No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound imaging modes and measurements.
No
The device is described as a "diagnostic ultrasound system" and its purpose is for "clinical diagnosis purposes," not for treating conditions.
Yes
The Device Description explicitly states: "The SONOLINE Versa Pro is a general purpose, mobile, software-controlled, diagnostic ultrasound system." Additionally, the Intended Use / Indications for Use section mentions that its analysis packages "provide information that is used for clinical diagnosis purposes."
No
The device description explicitly states it is a "diagnostic ultrasound system" and mentions acquiring ultrasound data and displaying it on a CRT display, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The SONOLINE Versa Pro is a diagnostic ultrasound system. It uses sound waves to create images of internal body structures. This is an in vivo diagnostic method, meaning it is performed within the living body.
- Intended Use: The intended uses listed (General Radiology, Abdominal, OB/GYN, etc.) are all applications of imaging internal anatomy, not analyzing samples taken from the body.
- Device Description: The description details how the system acquires and displays ultrasound data, which is consistent with an imaging device, not a device that analyzes biological samples.
Therefore, the SONOLINE Versa Pro is a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SONOLINE Versa Pro ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal Cephalic, Urology, Vascular, Peripheral Vascular, and Laparoscopic applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Product codes
90 YIN
Device Description
The SONOLINE Versa Pro is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Flow Modes, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasound
Anatomical Site
General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal Cephalic, Urology, Vascular, Peripheral Vascular
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
510(K) SUMMARY
SONOLINE ® Versa Pro Diagnostic Ultrasound System, Addition of 6.5 MHz Laparoscopic Probe
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
- Submitted By: 1. Siemens Medical Systems, Inc., Ultrasound Group 22010 SE 51st Street Issaquah, WA 98027-7002
Contact Person:
Steve Hesler Manager of Requlatory Affairs (206) 557-1629
Date Prepared: July 22, 1996
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- Proprietary Name: SONOLINE Versa Pro Diagnostic Ultrasound System
Common/ Usual Name: Diagnostic Ultrasound System with Accessories
- Proprietary Name: SONOLINE Versa Pro Diagnostic Ultrasound System
Classification Name:
Ultrasonic Pulsed Doppler Imaging System (Product Code 90 YIN, 21 CFR 892.1550)
3. Predicate Device:
Siemens SONOLINE Versa Diagnostic Ultrasound System (K945773), 8/7/95. Tetrad Corp., Laparoscope Ultrasound Transducer (K924204), 6/7/93.
4. Device Description:
The SONOLINE Versa Pro is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Flow Modes, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display .
The SONOLINE Versa Pro has been designed to meet the following product safety standards:
APR 2 4 1997
1
- UL 2601, Safety Requirements for Medical Equipment ●
- CSA 22.2 No. 601-1, Safety Requirements for Medical Equipment .
- Standard for Real Time Display of Thermal and Mechanical Indices on . Diagnostic Ultrasound Equipment, AlUM/NEMA, 1992.
- 93/94/EEC Medical Devices Directive .
- EN60601 = (IEC 601-1-1 + IEC 601-1-2), Safety and EMC , Requirements for . Medical Equipment
5. Intended Uses:
The SONOLINE Versa Pro ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal Cephalic, Urology, Vascular, Peripheral Vascular, and Laparoscopic applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Technological Comparison to Predicate Device: 6.
The SONOLINE Versa Pro is identical to the SONOLINE Versa in that both incorporate software controlled electronics to transmit ultrasonic pulses, via a transducer, into a patient, then receive return (echo) pulses and to convert those pulses into a visual display, to be provide information for use in the diagnosis of various disease states as well as normal conditions such as pregnancy and physical development. The operating principles of both systems are identical.
The Siemens 6.5 MHz Laparoscopic Probe is technologically equivalent to the Tetrad Laparoscope in that both incorporate a linear array transducer of 6.0 MHz center frequency on the end of an articulating arm. Both are intended for intra-abdominal uttrasound examinations via small abdominal incisions.