(64 days)
Not Found
No
The description focuses on 3D rendering of sequential ultrasound images, which is a standard image processing technique and does not inherently involve AI/ML. There are no mentions of AI, ML, training data, or performance metrics typically associated with AI/ML devices.
No
The device is described as software that enables the storage and 3D visualization of sequential ultrasound images for display and manipulation, which is a diagnostic or image processing function, not a therapeutic one. The predicates are also imaging managers and ultrasound systems.
No
The device description states it stores and renders ultrasound images as 3D images for display, which is an image management and visualization function, not a diagnostic one. Additionally, none of the typical sections for diagnostic devices (e.g., performance studies, key metrics, intended use) are populated, and the predicate devices are image managers and ultrasound systems, not diagnostic tools themselves.
Yes
The device description explicitly states it is a "software module" that enables the storage and 3D rendering of ultrasound images. While it interacts with ultrasound transducers and systems (hardware), the device itself, as described in the submission, is the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a key indicator for IVDs. IVDs typically have specific intended uses related to diagnosing diseases or conditions based on in vitro examination of specimens.
- Device Description: The description focuses on storing, rendering, and displaying ultrasound images for 3D visualization. This is a function related to medical imaging and visualization, not the analysis of biological specimens outside the body.
- Input Imaging Modality: The input is "ultrasound," which is an in vivo imaging technique, not an in vitro diagnostic method.
- Predicate Devices: The predicate devices listed are "Dicom Image Manager" and "Ultrasound systems." These are consistent with medical imaging devices, not IVDs.
In summary, the device's function, input, and predicate devices all point towards it being a medical imaging software module for visualization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The software changes described in this submission enable the DICOMIT Dicom Image Manager - with 3D-visualization software module to store in memory, multiple sequential ultrasound images when using a standard ultrasound transducer during any standard ultrasound scanning procedure. These images can then be rendered as a 3D image that can be displayed and manipulated in "windows" on the monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
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)
Reference Device(s)
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
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).
0
4/16/99
Page A - 4 510(k) Notification DICOM IMAGE MANAGER - Addition of 3D Visualization Software Module 510 (k) SUMMARY
This following summary is provided as part of this Premarket Notification in compliance with and based on the format set forth in the Final Rule as published in the Federal Register, December 14, 1994. (See 21 CFR § 807.92)
(1) Submitters Name / Contact Person:
Dicomit Imaging Systems Corp. 75 East Beaver Creek Road, Unit 9 Richmond Hill, Ontario Canada L4B 1K6
| Contact Person: | Terry Callahan |
|---|---|
| Tel.: (905) 886-9496 | |
| Fax: (905) 886-2109 | |
| E-mail: tcallahan@dicomit.com |
January 22, 1999 Date prepared:
(2) Name of device:
| Trade Name: | Dicom Image Manager™ "3D ROI™" |
|---|---|
| Common Name: | 3D Visualization Module |
| Classification Name: | Ultrasonic Pulsed Echo Imaging System |
(3) Identification of predicate devices:
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Dicomit Imaging Systems Corp. | Dicom Image Manager | K951925 |
| Advanced Technology Labs | ATL HDI 3000/5000 Ultrasound systems | K961459 |
| General Electric Medical Systems | GE LOGIQ 700 Ultrasound system | K964617 |
(4) Description of the device:
The software changes described in this submission enable the DICOMIT Dicom Image Manager - with 3D-visualization software module to store in memory, multiple sequential ultrasound images when using a standard ultrasound transducer during any standard ultrasound scanning procedure. These images can then be rendered as a 3D image that can be displayed and manipulated in "windows" on the monitor.