(77 days)
No
The summary mentions "real-time image processing functions" but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. Image processing can be performed using traditional algorithms without AI/ML.
No
The device is described as a "spiral scanner" and a "CT scanner," which are diagnostic imaging devices used to capture images of the body, not to provide therapy.
Yes
The device is described as a "CT scanner" which is a type of medical imaging device used for diagnostic purposes.
No
The device description explicitly states it is a "spiral scanner," which is a hardware component (a type of CT scanner). While it mentions "real-time image processing functions," this processing is part of the overall hardware system, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on the device being a "spiral scanner" and its image processing capabilities. There is no indication that it is used to examine specimens (like blood, urine, or tissue) outside of the body.
- Input Modality is CT: CT scanners are used for in vivo imaging (imaging inside the body), not in vitro testing.
- Predicate and Reference Devices are CT scanners: The listed predicate and reference devices (HeliCAT, Exel 905 GT, AngioCT, ProVision) are all types of CT scanners or related imaging systems, further supporting that this device is for medical imaging of the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The description of the SeleCT/SP does not align with this purpose.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The SeleCT/SP is a cost effective spiral scanner, with compact siting requirements and real-time image processing functions.
Mentions image processing
real-time image processing functions.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
HeliCAT, K930090
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.
Exel 905 GT, K884667, AngioCT. K932508/B, ProVision by Algotec Ltd., Raanana, Israel, K954678
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
Summary of Safety and Effectiveness
1. Device Name
JUL - 3 1996
SeleCT/SP
2. Submitter
:
Elscint Inc., 505 Main Str. Hackensack, NJ 07601.
3. Description of Main Features
The SeleCT/SP is a cost effective spiral scanner, with compact siting requirements and real-time image processing functions.
4. Predicate Devices
- · HeliCAT, K930090.
- · Other related devices:
5. Safety
The SeleCT/SP complies with IEC601-1 safety standard. Its safety is not significantly different from the predicate device. HeliCAT.
Its scan modes and radiation doses are similar those of the predicate device.
The laser localizer system is Class I and does not therefore significantly change the safety of the device.
6. Effectiveness
The effectiveness of SeleCT/SP is not significantly changed in respect to the predicate device. HeliCAT: the longer scan time and smaller gantry aperture affect the convenience of use; the lower spatial resolution and X-ray power are similar to those of Exel 905 GT.
7. Substantial Equivalency Statement
Based on the above considerations, it is Elscint's opinion that the SeleCT/SP CT scanner is substantially equivalent in safety and effectiveness to the predicate device, HeliCAT, K930090.