(178 days)
No
The document describes a standard digital radiographic and fluoroscopic imaging system and does not mention any AI or ML capabilities in its intended use, device description, or performance studies.
No
The device is used for diagnostic imaging (radiographic and fluoroscopic studies) to visualize anatomical structures, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies."
No
The device description explicitly states that the Platinum dRF Imaging System is not a stand-alone device but functions as a platform for FDA cleared or registered components, including a radiological examination table, control panel with system controller software, and electrical panel. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The Platinum dRF Imaging System is an X-ray imaging system. Its purpose is to visualize anatomical structures within the body using X-rays. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "radiographic and fluoroscopic studies" and "to visualize anatomical structures by converting a pattern of X-ray into a visible image." This aligns with diagnostic imaging, not in vitro testing.
Therefore, the Platinum dRF Imaging System falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, diagnostic fluoroscopy, conventional linear tomography, angiography and pediatric examinations.
The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, digital angiography and digital subtraction angiography (DSA).
The Platinum dRF may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
The Platinum dRF is not indicated for use in interventional radiology.
Product codes
JAA
Device Description
The Apelem-DMS Platinum dRF Imaging System (Platinum) is not a stand-alone device, but functions as a platform for FDA cleared or registered components (i.e. generator, panel detector, detector collimator. X-ray tube and software imaging packages), that are installed with a Apelem-DMS manufactured radiological examination table, control panel with system controller software. and electrical panel.
The Platinum dRF remote controlled table is a radiologic table equipped with a flat panel electronic detector. This table is used to perform general digital radiological, fluoroscopy and peripheral angiography. This device allows for treatment on the whole body, using all angles. It allows the user dynamic acquisition for the whole body, to target the zones to analyze, and to be able to track contrast media.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
gastrointestinal, cranial, skeletal, thoracic, lung, urogenital tract
Indicated Patient Age Range
pediatrics
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)
The Platinum is not a stand-alone device, but functions as a platform for FDA cleared or registered components. The Platinum is manufactured with FDA cleared/registered commercially available imaging components. Data as required in the appropriate sections of 21 CFR 1020 have been generated by the appropriate component manufacturer, and included in their manuals. Data generated by Apelem-DMS is limited to that required in CFR 1020.31(e)(1). No additional special imaging performance testing was conducted.
Electrical/EMC testing was successfully conducted per the standards listed below.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K062623 Siemens AXIOM Luminos dRF
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression 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
DEC 1 2 2013
K131766
Page 1 of 4
Traditional 510(k) Summary as required by 21 CFR 807.92(a)
| A) Submitted by: | APELEM- DMS GROUP |
|---|---|
| Parc Scientifique Georges Besse | |
| 175 Allée Von Neumann. 30035 Nîmes cedex 1 | |
| France | |
| Phone : +33 (0)4 67 50 49 00 | |
| Fax : +33 (0)4 67 50 40 09 |
Sharyn Orton. Ph.D. Contact: MEDIcept. Inc. 200 Homer Ave. Ashland. MA 01721
| B) Date Prepared: | October 24. 2013 |
|---|---|
| C) Common Name: | System, X-Ray Fluoroscopic. Image-Intensified |
| Proprietary Name: | Platinum dRF Imaging System |
| Device Regulations and Class: | 21 CFR 892.1650. Class II |
| Product Code: | JAA |
| Classification Panel: | Radiology |
| C) Predicates: | K062623 Siemens AXIOM Luminos dRF |
D) Device Description:
The Apelem-DMS Platinum dRF Imaging System (Platinum) is not a stand-alone device, but functions as a platform for FDA cleared or registered components (i.e. generator, panel detector, detector collimator. X-ray tube and software imaging packages), that are installed with a Apelem-DMS manufactured radiological examination table, control panel with system controller software. and electrical panel.
The Platinum dRF remote controlled table is a radiologic table equipped with a flat panel electronic detector. This table is used to perform general digital radiological, fluoroscopy and peripheral angiography. This device allows for treatment on the whole body, using all angles. It allows the user dynamic acquisition for the whole body, to target the zones to analyze, and to be able to track contrast media.
1
E) Intended Use/Indication for Use: The Platinum dRF Imaging Svstem is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, diagnostic fluoroscopy. conventional linear tomography, angiography and pediatric examinations.
The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, digital angiography and digital subtraction angiography (DSA).
The Platinum dRF may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
The Platinum dRF is not indicated for use in interventional radiology.
F) Comparison to Predicate Device(s):
| | Platinum dRF Imaging System | Siemens AXIOM Luminos dRF
K062623 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Product code | JAA | JAA, OWB. OXO |
| Components | | |
| Flat detector | Trixell Pixium RF 4343
(K080859) | Trixell Pixium RF 4343 |
| Collimator | RALCO R225 ACS
(K091517) | Self manufactured |
| Type | Motorized, remote controlled, with
± 45° manual rotation according to
a vertical axis. automatic lighting
on, including positioning camera | Motorized up to a maximum of ±
45°. detent at 0° |
| Field coverage | min 4X4 and max 48X48 at
100 cm source to image distance | min/max not reported |
| Generator | CMT Indico 100 Series | Self manufactured |
| Power | 50-80 kW | 65 kW or 80 kW (optional) |
| AEC Interface | 4 ionization chambers max (solid
state ionization 3 fields) | Not available |
| X-ray tube | Varian 600 kHU tubes RAD92 and
G292: 400 kHU tube RAD60 | Self manufactured |
| Use with X-ray
ceiling tube | Yes | Yes |
| X-ray Grid | Smit Röntgen | Self manufactured |
| Tube motorized
rotation | +180°/-180° | +180/-90° |
2
| | Platinum dRF Imaging System | Siemens AXIOM Luminos dRF
K062623 |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Oblique | 45°/-45° motorized adjustment of | 40°/-40°: motorized adjustment of |
| projections | the height of the rotation axis from | the height of the rotation axis from |
| | 10 to 450 mm above the table (to | 10 to 300 mm above the table (to |
| | correct object parallax) | correct object parallax) |
| | The angle is displayed on both the | The angle is displayed on both the |
| | control console and on the table's | control console and on the table's |
| | control panel | control panel |
| Distance between | 6.2 cm | 7 cm |
| table-top and | | |
| detector
Anti-diffusion | Oscillating: ratio 10:1, 12:1 / | Fixed : ratio 15:1. 80 lignes/cm, f0 |
| grid | 401:cm - 60 1:cm / Multifocus 140 | = 125 cm, easy ejection from the |
| | cm for exams in the range of 110 to | front of the table |
| | 180 cm : easy ejection from the | |
| | front of the table | |
| Movement of the | Max 158 cm (remotely), | Max 113 cm (remotely). |
| AB selector | adjustments by increments up to 6 | adjustments by increments up to 7 |
| | cm/sec | cm/sec : PERISTEPPING step to |
| | | step movements of 25 cm each |
| Compression | 0-160 N with a compression | 5-155N |
| cone | indication above 3 kg | |
| Imaging Software | CMT Thales Duet | Flurospot COMPACT digital |
| | (K103028) | imaging system |
| Image resolution | 3.4 lp/mm | 3.4 lp/mm |
| Speed | 12 f/s (RAD) | 8 f/s (RAD) |
| | 18 f/sec for fluoroscopy (large | 15 f/s for fluoroscopy |
| | field) | |
| Dose Reduction | Yes | Yes |
| DICOM | Yes | Yes |
| DAP measuring | 0.1 - 99 999 999 µGy.m2 | Not available |
| range | | |
| Pulse frequency | 15, 7.5 and 3 pulsed per sec | 15, 10, 7.5 and 3 pulsed per sec |
| | Platinum dRF Imaging System | Siemens AXIOM Luminos dRF
K062623 |
| Table
specifications | | |
| Table Tilting | +90°/-90° | +90°/-45° or +90°/-90° (optional) |
| | Variable tilting up to 10°/sec | Two speeds about 3°/sec and
6°/sec. |
| | | Time for complete tilt +90° to 0° :
17 sec |
| | Automatic stop in the 0° position is
possible / angle indication on the
remote control panel as well as the
panel on the front of the table. | Automatic stop in the 0° position
is possible / angle indication on
the remote control panel as well as
the panel on the front of the table. |
| Table top height | 50 cm to 130 cm continuously
adjustable, about 4 cm/sec | 50 cm to 100 cm continuously
adjustable. about 4 cm/sec |
| | 48 cm - 128 cm with the base plate | 48 cm - 98 cm with the base plate
not encrusted in the floor |
| Table top | 240 x 85 cm / radio transparent
field: 283 x 65 cm / surface
inalterable / sliding rail system | 210 X 80 cm / radio transparent
field : 193 x 53.5 cm / surface
inalterable / sliding rail system |
| | Equivalent attenuation value :
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