(218 days)
Not Found
No
The summary does not mention any AI or ML capabilities, image processing beyond standard ultrasound functions, or details about training or test sets typically associated with AI/ML development.
No
The RT55 portable ultrasound system is described as a "diagnostic system" used to "aid in the diagnosis and evaluation of soft tissues by generating two dimensional images, time-motion images and biometric data." It does not mention any therapeutic capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "to aid in the diagnosis and evaluation of soft tissues".
No
The device description explicitly states it is a "portable ultrasound system weighing less than 10 kg" with an "integrated monitor and keyboard" and supports "linear, convex and micro convex probes," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for generating images and biometric data to aid in the diagnosis and evaluation of soft tissues. This is a function of medical imaging, not in vitro testing of samples from the body.
- Device Description: The description details a portable ultrasound system with probes, monitor, and keyboard, consistent with an imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates by using ultrasound waves to create images of internal structures.
N/A
Intended Use / Indications for Use
The RT55 portable ultrasound diagnostic system is intended for use in obstetrics, gynecology and general radiology examinations by a qualified physician to aid in the diagnosis and evaluation of soft tissues by generating two dimensional images, time-motion images and biometric data. The specific intended uses of this system include: abdominal, small parts, pediatric and fetal imaging.
Product codes
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Device Description
The RT55 is a portable ultrasound system weighing less than 10 kg .. approximately 28 cm wide, 41 cm deep and 29 cm high with integrated monitor and keyboard. The system is designed for use in linear and convex scanning modes and supports linear, convex and micro convex probes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
soft tissues, abdominal, small parts, pediatric and fetal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
GE RT55 510k Premarket Notification August 8, 1995
KG53752 MAR 15 1996
953752
Attachment A
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
| Identification of Submitter: | GE Medical Systems
PO Box 414
Milwaukee, WI 53201 |
|------------------------------|----------------------------------------------------------|
| Contact : | Allen Schuh, Manager, Regulatory Program
414-548-4839 |
| Date Prepared: | July 20, 1995 |
Product Identification: GE RT55 Diagnostic Ultrasound System
Marketed Devices: The GE RT55 is of a comparable type and substantially equivalent to the GE Medical Systems RT2800 diagnostic ultrasound system, 510(k) Number K873700, currently in commercial distribution:
Device Description: The RT55 is a portable ultrasound system weighing less than 10 kg .. approximately 28 cm wide, 41 cm deep and 29 cm high with integrated monitor and keyboard. The system is designed for use in linear and convex scanning modes and supports linear, convex and micro convex probes.
Indications for Use: The RT55 portable ultrasound diagnostic system is intended for use in obstetrics, gynecology and general radiology examinations by a qualified physician to aid in the diagnosis and evaluation of soft tissues by generating two dimensional images, time-motion images and biometric data. The specific intended uses of this system include: abdominal, small parts, pediatric and fetal imaging.
Comparison with Predicate Device: The GE RT55 is comparable in key safety and effectiveness features, uses similar design, construction, and materials, and has the same intended uses and operating modes as the predicate device.
Summary of Studies: The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with GMP standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE RT55 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.