(444 days)
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No
The summary describes a standard ultrasound system with various imaging modes and measurement capabilities, but there is no mention of AI, ML, or related concepts in the device description, intended use, or specific sections for AI/ML details.
No
The device is described as a "diagnostic ultrasound system" intended for "clinical diagnosis purposes" and not for treatment.
Yes
The device description explicitly states, "The Q64XXX is a general purpose, mobile, software-controlled, diagnostic ultrasound system." Additionally, the Indications for Use mention "analysis packages that 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.
- Device Description: The Q64XXX is an ultrasound imaging system. It uses sound waves to create images of internal body structures. This is an in vivo (within the living body) diagnostic method, not in vitro.
- Intended Use: The intended uses listed are all related to imaging internal anatomical structures and analyzing those images for clinical diagnosis. This aligns with the function of an ultrasound system.
Therefore, the Q64XXX ultrasound imaging system is a diagnostic imaging device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Q64XXX ultrasound imaging system is intended for the following applications: General Radiology; Abdomen; Intraoperative; Small Parts; Transcranial; OB/GYN; Neonatal Cephalic; Urology; Vascular; Peripheral Vascular: Vascular Doppler.
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 IYN, 90 ITX
Device Description
The Q64XXX 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 Mode, 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
Abdomen; Intraoperative; Small Parts; Transcranial; OB/GYN; 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.
Siemens Quantum™ 2000 Ultrasound System (K904019/A), Assorted Diagnostic Ultrasound Transducers (K904019/A), Siemens SONOLINE™ SI1200 Ultrasound System (K904564/A)
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.
Not Found
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
§ 892.1560 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.
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SECTION 7
Ultrasound Group
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4-R . 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5750157
Q64XXX 510(K) SUMMARY
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.
1. Submitted By:
Siemens Medical Systems, Inc., Ultrasound Group 22010 S.E. 51st Street Issaquah, WA 98027-7002
Contact Person:
Steve Hesler Manager of Regulatory Affairs (206) 557-1629
Date Prepared:
January 16, 1995
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- Proprietary Name: Q64XXX Diagnostic Ultrasound System
Common/ Usual Name:
Diagnostic Ultrasound System with Accessories
Classification Name:
Ultrasonic Pulsed Doppler Imaging System (Product Code 90 IYN, 21 CFR 92.1550)
Diagnostic Ultrasonic Transducer:
(Product Code 90 ITX, 21 CFR 892.1570)
3. Predicate Device:
- Siemens Quantum™ 2000 Ultrasound System (K904019/A) .
- . Assorted Diagnostic Ultrasound Transducers (K904019/A)
- Siemens SONOLINE™ SI1200 Ultrasound System (K904564/A) •
1
Device Description: 4.
The Q64XXX 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 Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display .
The Q64XXX, has been designed to meet the following product safety standards:
- UL 544, 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, AIUM/NIEMA, 1992.
- . CE Mark and CB Certificate Certifying Compliance To:
EN29001. Quality Systems
EN46001. Quality Systems for Medical Device Manufacturers
- 89/336/EEC EMC Directive .
EN 50081-2. Electromagnetic Emissions Requirements
EN 55011B, Group 1 = CISPR 11B, Group 1, RF Radiated/Conducted Emission Limits
EN 50082-2, Electromagnetic Immunity Requirements
IEC 801-2. Electrostatic Discharge Immunity
IEC 801-3. Radiated RF Field Immunity
IEC 801-4, Power Line Fast Transient/Burst Immunity
- 93/94/EEC Medical Devices Directive .
EN60601 = (IEC 601-1-1 + IEC 601-1-2), Safety and EMC Requirements for Medical Equipment
CISPR11B, Group 1 = EN55011B, Group 1 CISPR14, subclause 4.2 (clicks) = EN 55014, Intermittent Radiated RF Emissions Limits
IEC 801-5 (draft), Power Line Surge Immunity
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Intended Uses: 5.
The Q64XXX ultrasound imaging system is intended for the following applications: General Radiology; Abdomen; Intraoperative; Small Parts; Transcranial; OB/GYN; Neonatal Cephalic; Urology; Vascular; Peripheral Vascular: Vascular Doppler.
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 Q64XXX is similar to the Quantum™ 2000 and the SONOLINE® SI1200 in that all three incorporate software controlled electronics to transmit ultrasonic pulses, via an applicator/transducer, into a patient, then receive return (echo) pulses and to convert those pulses into a visual display, to be used for diagnosis of various disease states. The operating principles of all three systems are the same. However, the Q64XXX incorporates an on-screen display of Mechanical (MI) and Thermal (TI) Indices, in compliance with the Standard for Real Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound Equipment, AIUM/NEMA, 1992.