(80 days)
Not Found
No
The summary describes a digital dental radiography system with image processing capabilities, but there is no mention of AI or ML algorithms being used for image analysis, interpretation, or any other function. The focus is on image capture, digitization, storage, and basic processing for viewing.
No
The device is described as a "digital dental radiography system" used for "diagnostic intraoral and extraoral dental images," which indicates it is for imaging and diagnosis, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" states that the system is for "radiographic diagnostic intraoral and extraoral exposures," clearly indicating its use in diagnosing.
No
The device description explicitly lists multiple hardware components, including a scanner, workstation computer, CRT monitor, keyboard, mouse, floppy drive, optical hard drive, laser printer, and light box. This indicates it is a system with both hardware and software, not a software-only device.
Based on the provided information, the ALARA Imaging System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states it's for "digital dental radiography system for using X-ray recording media... for radiographic diagnostic intraoral and extraoral exposures". This describes an imaging system used to capture and process images of the patient's anatomy (teeth and surrounding structures) using X-rays.
- Device Description: The components listed are all related to capturing, processing, viewing, and storing radiographic images. There are no components or processes described that involve testing samples taken from the body (like blood, urine, tissue, etc.), which is the hallmark of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information based on laboratory tests.
In summary, the ALARA Imaging System is a medical imaging device used for diagnostic purposes based on radiographic images of the patient's anatomy, not an IVD which performs tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The ALARA Imaging System is indicated for use digital dental radiography system for using X-ray recording media (phosphor storage screens) for radiographic diagnostic intraoral and extraoral exposures providing interactive CRT retrieval, viewing and processing of stored computed radiographic images.
Product codes
90 IXK
Device Description
The ALARA Imaging System is digital dental radiography system for using X-ray recording media (phosphor storage screens) for radiographic diagnostic intraoral and extraoral dental images. ALARA Imaging System is comprised of the following main components: Reusable phosphor storage screens (Denta-screens) with commercially available ● disposable storage screen covers; . The ALARA Scanner, an image reader/digitizer (laser scanner and optical reader); The ALARA Scanner/Workstation Communications Interface; ● The ALARA Imaging System Workstation, with a CRT monitor, a workstation computer (the image processor), a keyboard and mouse (operator interface), proprietary workstation software, a floppy drive, and an optical hard drive (or digital analog tape) that is either resident in or attached to the workstation computer (image storage devices); A compatible commercially available laser printer (hard copy device); . A commercially available light box used to "erase" the phosphor storage screen . "eraser"; and . Any compatible commercially available mass storage device(s) as backup electronic archive device(s).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
intraoral and extraoral dental
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)
Physical testing was performed to demonstrate that the performance of the DenOptix phosphor storage screens with the ALARA Imaging System is in accordance with the product specifications and equivalent to the labeled performance of the Digora device. In addition, the plastic envelope material that is used to cover the storage phosphor screens is a commercially available biocompatible product that is used to cover dental X-Ray film to provide protection from cross-contamination.
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.
K934949, K924459, K884621, K924012, K923990
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
Not Found
§ 892.1900 Automatic radiographic film processor.
(a)
Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Attachment 14 510(k) Summary Statement for the ALARA Imaging System
I. General Information
DenOptix Inc. Submitter: 270 Santa Ana Court Sunnyvale, CA 94086
Contact Person: Joseph Rimsa
Summary Preparation Date: December 11, 1995
II. Names
ALARA Imaging System Device Names:
Electrostatic X-ray Imaging System (90 IXK) Primary Classification Name:
III. Predicate Devices
- Digora device (K934949), marketed by Orion/Soredex; .
- DIGISCAN 2 and DIGISCAN (K924459 and K884621), marketed by Siemens ● Medical Systems, Inc .;
- Computed Radiography DMS CRT Image Consoles (K924012 and K923990), ● marketed by Fuji Medical Systems USA, Inc.
IV. Product Description
The ALARA Imaging System is digital dental radiography system for using X-ray recording media (phosphor storage screens) for radiographic diagnostic intraoral and extraoral dental images.
ALARA Imaging System is comprised of the following main components:
- Reusable phosphor storage screens (Denta-screens) with commercially available ● disposable storage screen covers;
- . The ALARA Scanner, an image reader/digitizer (laser scanner and optical reader);
- The ALARA Scanner/Workstation Communications Interface; ●
- The ALARA Imaging System Workstation, with a CRT monitor, a workstation computer (the image processor), a keyboard and mouse (operator interface), proprietary workstation software, a floppy drive, and an optical hard drive (or digital analog tape) that is either resident in or attached to the workstation computer (image storage devices);
- A compatible commercially available laser printer (hard copy device); .
- A commercially available light box used to "erase" the phosphor storage screen . "eraser"; and
- . Any compatible commercially available mass storage device(s) as backup electronic archive device(s).
1
V. Indications for Use
The ALARA Imaging System is indicated for use digital dental radiography system for using X-ray recording media (phosphor storage screens) for radiographic diagnostic intraoral and extraoral exposures providing interactive CRT retrieval, viewing and processing of stored computed radiographic images.
VI. Rationale for Substantial Equivalence
The ALARA Imaging System shares the same indications for use, similar materials and design features, functional features, and therefore are substantially equivalent to the Digora device (K934949), marketed by Orion/Soredex, the DIGISCAN 2 and DIGISCAN devices (K924459 and K884621), marketed by Siemens Medical Systems, Inc., and the Computed Radiography DMS CRT Image Consoles (K924012 and K923990), marketed by Fuji Medical Systems USA, Inc.
VI. Safety and Effectiveness Information
Physical testing was performed to demonstrate that the performance of the DenOptix phosphor storage screens with the ALARA Imaging System is in accordance with the product specifications and equivalent to the labeled performance of the Digora device. In addition, the plastic envelope material that is used to cover the storage phosphor screens is a commercially available biocompatible product that is used to cover dental X-Ray film to provide protection from cross-contamination.
VI. Conclusion
The ALARA Imaging System was found to be substantially equivalent to the currently marketed predicate devices, the Digora, the DIGISCAN 2 and DIGISCAN, and the Computed Radiography DMS CRT Image Consoles. The ALARA Imaging Systems share the same indications for use, similar design features, and similar functional features as the currently marketed Digora, DIGISCAN 2 and DIGISCAN, and Computed Radiography DMS CRT Image Consoles. The physical test results demonstrated that the Alara imaging system have acceptable performance characteristics.
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