(14 days)
Not Found
No
The document describes a standard CT scanner with image reconstruction capabilities, but there is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on hardware specifications and basic image processing.
No
The device is described as an imaging system used to produce images of the head and whole body by computer reconstruction of X-ray transmission data, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" states that the systems are "intended to produce images of the head and whole body by computer reconstruction of X-ray transmission data at different angle and planes." Producing images of the internal body for medical evaluation is a fundamental function of diagnostic devices.
No
The device description clearly outlines physical hardware components such as a gantry, patient table, operator console, High Voltage Power Supply, detector, and monitors, in addition to the software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The SyneRad Impact 60, SyneRad Impact 72, and Analogic AMS1600 are Computed Tomography (CT) X-ray Systems. Their function is to produce images of the inside of the body using X-rays and computer reconstruction.
- Lack of Specimen Analysis: The description clearly states the device produces images of the head and whole body by analyzing X-ray transmission data. There is no mention of analyzing biological specimens.
Therefore, based on the provided information, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The SyneRad Impact 60, SyneRad Impact 72 and Analogic AMS1600 are Computed Tomography X-ray Systems intended to produce images of the head and whole body by computer reconstruction of X-ray transmission data at different angle and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Product codes (comma separated list FDA assigned to the subject device)
90JAK
Device Description
The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 Multislice Computed Tomography Systems consist of a gantry, a patient table and an operator console.
All three CT Systems are virtually identical. The physical size of all three systems is the same and they use the same control console, operating system and software. The Analogic AMS1600 is the platform from which the two Anexa systems are built and is identical in construction (except for cosmetics created by the covers) to the SyneRad IMpact 72. The difference between the SyneRad IMPACT 60 and the SyneRad IMpact 72 is the output rating of the High Voltage Power Supply mounted on the gantry. The SyneRad IMPACT 60 has a 60 kW PSU whereas the SyneRad IMpact 72 has a 72 kW PSU. The kVp levels are the same for both systems. The upper mA setting for the 60 kW system is 500 mA. The upper mA setting for the 72 kW system is 600 mA. The High Voltage Power Supply provides feedback to the control computer which selects the upper mA limit.
These 16-slice CT scanners have a gantry aperture opening of 70 centimeters. They are based on proven Analogic computed tomography technology. They have a 16-row detector and a 0.50 second minimum scan time. High-speed image reconstruction is from an innovative reconstruction engine. The operator console is supplied with two 20-inch high resolution monitors. 3D software is standard. Workflow and patient throughput requirements are supported by local archiving and DICOM-based interconnectivity features.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
head and whole body
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)
Bench testing demonstrates that the SyneRad IMPACT 60, SyneRad IMPACT 72 and the Analogic AMS1600 comply with 21CFR Subchapter J.
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.
K033502, K030420, K020385, K022050
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. 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
Kos 2447
SEP 2 1 2005
510(k) SUMMARY
FOR
Analogic Corporation
SyneRad IMPACT 60, SyneRad IMpact 72 and Analogic AMS1600 Submitter's Name and Address
| Submitter's Name: | Analogic Corporation | ||
|---|---|---|---|
| Address: | 8 Centennial Drive | ||
| City, State, and Zip: | Peabody, MA, 01960 |
Contact Person
| Name: | Donald J Sherratt |
|---|---|
| Title: | Director of Regulatory Affairs |
| Telephone: | ( 978 ) 977-3000 extension 4075 |
| Facsimile: | ( 978 ) 977-6808 |
| E-mail: | dsherratt@analogic.com |
Manufacturing Facility Address
| Manufacturer: | Analogic Corporation |
|---|---|
| Address: | 8 Centennial Drive |
| City, State, and ZIP: | Peabody, MA, 01960 |
Establishment Registration Number
Est. Registration Number: 1220672
New Device Details
Proprietary of Trade Names
| Proprietary or Trade
Name: | SyneRad IMPACT 60
SyneRad Impact 72 and
Analogic AMS1600 |
| ------------------------------- | ---------------------------------------------------------------- |
|---|
New Device Common Name
Common Name:
Computed Tomography X-ray system
New Device Class
Device Class:
Class II
1
New Device Product Code
Device Procode:
| New Device CFR | |
|---|---|
| Device CFR: | 892.1750 |
| New Device Classification Panel | |
| Classification Panel: | Radiology |
| New Device Classification Name | |
| Classification Name: | System, X-ray, Tomography, Computed |
| Reason for submission | |
| Reason for submission | New Devices |
| Comparison with predicates | |
| Predicate #1 | |
| K033502 | GE Lightspeed 6.0 CT Scanner System |
| Predicate #2 | |
| K030420 | GE Lightspeed 5.0 CT Scanner System |
90JAK
Description of These Devices
The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 Multislice Computed Tomography Systems consist of a gantry, a patient table and an operator console.
Predicate #3 K020385, K022050 Toshiba Aquilion 16 CFX
All three CT Systems are virtually identical. The physical size of all three systems is the same and they use the same control console, operating system and software. The Analogic AMS1600 is the platform from which the two Anexa systems are built and is identical in construction (except for cosmetics created by the covers) to the SyneRad IMpact 72. The difference between the SyneRad IMPACT 60 and the SyneRad IMpact 72 is the output rating of the High Voltage Power Supply mounted on the gantry. The SyneRad IMPACT 60 has a 60 kW PSU whereas the SyneRad IMpact 72 has a 72 kW PSU. The kVp levels are the same for both systems. The upper mA setting for the 60 kW system is 500 mA. The upper mA setting for the 72 kW system is 600 mA. The High Voltage Power Supply provides feedback to the control computer which selects the upper mA limit.
2
These 16-slice CT scanners have a gantry aperture opening of 70 centimeters. They are based on proven Analogic computed tomography technology. They have a 16-row detector and a 0.50 second minimum scan time. High-speed image reconstruction is from an innovative reconstruction engine. The operator console is supplied with two 20-inch high resolution monitors. 3D software is standard. Workflow and patient throughput requirements are supported by local archiving and DICOM-based interconnectivity features.
Summary of Intended Uses
The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS 1600 are Computed Tomography X-ray Systems intended to produce images of the head and whole body by computer reconstruction of X-ray transmission data at different angle and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Comparison of Technological Characteristics
The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 Multislice Computed Tomography Systems utilize the same technological characteristics and operating principles, are comparable in key safety and effectiveness and QA features, and uses the same basic design, construction and materials.
They also have the same intended use and modes of operation (CT scanning throughout the whole body including Spiral, Axial, Dynamic, Scout modes, additional optional scan modes like CT fluoro and ECG gated acquisition). Their X-ray power and technique factors are comparable to the predicate devices. They also have comparable image quality performance (measured on phantoms) as the predicate devices. The control console displays weighted CTDI, Dose Length Product and geometric efficiency in a method similar to the predicate devices.
In the opinion of Analogic Corporation, the SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 are of comparable type and substantially equivalent to the currently marketed head and whole body X-ray computed tomography systems that comply with the same or equivalent standards and have the same intended use. These new devices will be certified to comply with the X-ray requirements of 21CFR1020.30 and 1020.33 as well as the safety requirements of UL 60601-1 and IEC 60601-1 and associated collateral and particular standards.
| Anexa | G. E. Healthcare | Toshiba | |||
|---|---|---|---|---|---|
| Model | IMPACT72 | IMPACT 60 | LightSpeed 6.0 | ||
| (LightSpeed Pro16) | LightSpeed 5.0 | ||||
| (LightSpeed 16) | AQUILION 16 CFX | ||||
| K Number | New Devices | K033502 | K030420 | K020385 and K022050 | |
| Spiral, Axiel, Dynamic and Scout Scanning | Yes | Yes | Yes | Yes | |
| CT fluoro end ECG gated scan mode | Optional | Optional | Optional | Optional | |
| kW output | 72 kW | 60 kW | 100 kW | 53.2 kW | 60 kW |
| kVp Range | 80, 100, 120, 140 kVp | 80, 100, 120, 140 kVp | 80, 100, 120, 140 kVp | 80, 100, 120, 140 kVp | 80, 100, 120, 135 kVp |
| mA Range | 10 - 600 mA | 10 - 500 mA | 10 - 800 mA | 10 - 440 mA | 10 - 500 mA |
| High Contrast Spatial Res. | |||||
| 0% MTF, lp/cm | 17.25 lp/cm | 17.25 lp/cm | 15.4 lp/cm | 15.4 lp/cm | 18 lp/cm |
| 50% MTF, lp/cm | 8+ lp/cm | 8+ lp/cm | 8.5 lp/cm | 8.5 lp/cm | 9.4 lp/cm |
| Low-contrast res., mm @ % @ 4 rads | 5 mm @ 0.30%, | ||||
| 8" CATPHAN | 5 mm @ 0.30%, | ||||
| 8" CATPHAN | 5 mm @ 0.30%, | ||||
| 8" CATPHAN | 5 mm @ 0.30%, | ||||
| 8" CATPHAN | 5 mm @ 0.3% @ 21.8 mGy (per MHRA) | ||||
| Weighted CTDI shown on console | Yes | Yes | Yes | Yes | |
| Dose Length Product shown on console | Yes | Yes | Yes | Yes | |
| Geometric Efficiency displayed on console when |