(351 days)
Not Found
No
The document describes standard digital image acquisition, processing, and management software. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is used for verification of excised tissue during biopsy, which is a diagnostic purpose, not therapeutic. It does not treat or cure a disease or condition.
Yes
The device is used for "rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy," which is a diagnostic purpose.
No
The device description explicitly states it includes hardware components such as a flat panel CMOS detector, scintillator technologies, power supply, cables, and mechanical accessories, which are installed permanently in the host cabinet x-ray unit. While it includes software, it is not solely software.
Based on the provided information, the Bioptics 10 X 10 VISION is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The Bioptics 10 X 10 VISION is used for digital specimen radiography to verify that the correct tissue has been excised during a biopsy. While it examines a specimen, the primary purpose is to confirm the physical presence of the tissue removed, not to perform diagnostic tests on the tissue itself (e.g., analyzing biomarkers, genetic material, etc.).
- The intended use is for rapid verification of tissue excision. This is a procedural check during a medical procedure, not a diagnostic test performed on a sample in a laboratory setting.
- The device description focuses on imaging technology. It describes a digital x-ray imager and associated software for image acquisition, display, and management. This aligns with medical imaging devices, not IVDs.
- The predicate device is a specimen radiography system. The predicate device (MammoPath®) is also a system for specimen radiography, further indicating that this device falls under the category of medical imaging equipment, not IVDs.
In summary, the Bioptics 10 X 10 VISION is a medical imaging device used to visualize excised tissue specimens, not a device used to perform diagnostic tests on those specimens in vitro.
N/A
Intended Use / Indications for Use
Bioptics intends that the submitted device's intended uses include and limited to the following:
- digital specimen radiography with 21 CFR 1020.40 compliant ,shielded x-ray cabinets .
The 10 X 10 VISION will be used by trained medical and technical staff in an appropriate medical facility or clinic environment.
The Bioptics 10 X 10 VISION is a digital upgrade to previously released 21 CFR 1020.40 compliant cabinet x-ray systems. The 10 X 10 Vision is used for digital specimen radiography to provide rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy. The 10 X 10 Vision is excluded from any use in in-vivo diagnostic or screening mammography applications.
Product codes
90 MWP, MWP
Device Description
The 10 X 10 VISION will be marketed as a digital specimen radiography add-on upgrade for standard film-based cabinet x-ray systems. using high-performance, flat panel CMOS detector, and high-resolution Gd202S:Tb (Gadolinium Oxysulfide) scintillator technologies.
Bioptics digital x-ray imagers are packaged in a thin (
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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 radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray 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
JUN 1 5 2010
PREMARKET NOTIFICATION 510(k) SUMMARY As required by §807.92
Device Name – as required by 807.92(a)(2):
| Trade Name: | 10 X 10 VISION |
|---|---|
| Common/Classification Name: | Stationary X-Ray System |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code (Procode): | 90 MWP |
| Premarket Notification submitter: | |
| Company Name: | Bioptics, Inc. |
| Company Address: | 3440 E. Britannia Dr. Suite 150 |
| Tucson, AZ 85706 | |
| Contact: | Akif Baysal |
| Preparation Date: | 2/21/2009 |
LEGALLY MARKETED PREDICATE DEVICE - as required by 807.92(a)(3) A.
The submitted device, 10 X 10 VISION, is substantially equivalent to the MammoPath® [registered trade mark of Fischer Imaging Technologies, Denver, Colorado- Stationary X-Ray System, K021113.
DEVICE DESCRIPTION - as required by 807.92(a)(4) B.
The 10 X 10 VISION will be marketed as a digital specimen radiography add-on upgrade for standard film-based cabinet x-ray systems. using high-performance, flat panel CMOS detector, and high-resolution Gd202S:Tb (Gadolinium Oxysulfide) scintillator technologies.
Bioptics digital x-ray imagers are packaged in a thin (X AND/OR Over-The-Counter Use |
| ------------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
(Division Sigh-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K091928