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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Apelem-DMS Platinum dRF Imaging System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. This type of submission often focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than performing extensive novel clinical trials as might be seen for entirely new technologies. Therefore, some detailed information about performance comparisons or AI assistance might not be present as it's not typically required for this type of submission.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format with specific thresholds. Instead, it relies on demonstrating substantial equivalence to a predicate device (Siemens AXIOM Luminos dRF). The performance is discussed in terms of similarities and improvements compared to the predicate, with the underlying assumption that if it's equivalent or better in relevant aspects, it meets necessary performance standards.

The table below summarizes the comparison:

Feature / Acceptance Criteria (Implied)	Platinum dRF Imaging System (Reported Performance)	Siemens AXIOM Luminos dRF (Predicate)	Notes / Implicit Acceptance
Product Code	JAA	JAA, OWB, OXO	Equivalent primary product code.
Flat Detector	Trixell Pixium RF 4343 (K080859)	Trixell Pixium RF 4343	Identical component, implying equivalent image quality at the detector level.
Collimator	RALCO R225 ACS (K091517)	Self manufactured	Different manufacturer, but accepted as equivalent.
Collimator Type	Motorized, remote controlled, with ± 45° manual rotation, automatic lighting, positioning camera	Motorized up to a maximum of ± 45°, detent at 0°	Platinum dRF offers more rotational flexibility and features than the predicate.
Field Coverage	min 4x4 and max 48x48 at 100 cm SID	min/max not reported	Platinum dRF provides specific field coverage details.
Generator Power	50-80 kW	65 kW or 80 kW (optional)	Overlaps with and potentially exceeds predicate's power output.
AEC Interface	4 ionization chambers max (solid state ionization 3 fields)	Not available	Platinum dRF offers an AEC interface not explicitly available on the predicate, an enhancement.
X-ray tube	Varian 600 kHU tubes RAD92 and G292: 400 kHU tube RAD60	Self manufactured	Different manufacturer, but accepted as equivalent.
Use with X-ray ceiling tube	Yes	Yes	Equivalent functionality.
X-ray Grid	Smit Röntgen	Self manufactured	Different manufacturer, but accepted as equivalent.
Tube motorized rotation	+180°/-180°	+180°/-90°	Platinum dRF offers greater rotational range.
Oblique projections (Rotational Angle)	45°/-45° motorized adjustment, height 10-450mm	40°/-40° motorized adjustment, height 10-300mm	Platinum dRF offers slightly larger angle and greater height adjustment range, implying enhanced patient positioning.
Distance between table-top and detector	6.2 cm	7 cm	Slightly smaller distance for Platinum dRF.
Anti-diffusion grid	Oscillating: ratio 10:1, 12:1 / 40 l:cm - 60 l:cm / Multifocus 140 cm, easy ejection	Fixed: ratio 15:1, 80 lignes/cm, f0 = 125 cm, easy ejection	Different specifications, but implies equivalent or improved anti-diffusion capabilities.
Movement of the AB selector	Max 158 cm (remotely), increments up to 6 cm/sec	Max 113 cm (remotely), increments up to 7 cm/sec, PERISTEPPING	Platinum dRF offers greater remote movement range.
Compression cone	0-160 N with indication above 3 kg	5-155 N	Platinum dRF offers a wider compression range, implying broader applicability.
Imaging Software	CMT Thales Duet (K103028)	Flurospot COMPACT digital imaging system	Different software, but both are standalone cleared/registered components.
Image Resolution	3.4 lp/mm	3.4 lp/mm	Identical, demonstrating equivalent image quality. This is a key technical specification for image performance.
Speed (Radiography)	12 f/s (RAD)	8 f/s (RAD)	Platinum dRF is faster, indicating an improvement.
Speed (Fluoroscopy)	18 f/sec (large field)	15 f/s	Platinum dRF is faster, indicating an improvement.
Dose Reduction	Yes	Yes	Equivalent functionality.
DICOM	Yes	Yes	Equivalent functionality.
DAP measuring range	0.1 - 99,999,999 µGy.m2	Not available	Platinum dRF includes DAP measurement, an enhancement for patient dose management.
Pulse frequency	15, 7.5 and 3 pulsed per sec	15, 10, 7.5 and 3 pulsed per sec	Slightly different options, but within acceptable range for fluoroscopy.
Table Tilting	+90°/-90°, variable tilting up to 10°/sec	+90°/-45° or +90°/-90° (optional), two speeds	Equivalent or improved tilting.
Table top height	50 cm to 130 cm continuously adjustable	50 cm to 100 cm continuously adjustable	Platinum dRF offers a greater adjustable height range, accommodating more patient types.
Table top dimensions	240 x 85 cm / radio transparent field: 283 x 65 cm	210 x 80 cm / radio transparent field: 193 x 53.5 cm	Platinum dRF has a larger table top and radio-transparent field, accommodating larger patients.
Table top attenuation value	<0.70 mm (+/- 0.1 Al à 100 kV/3.7 mm Al HVL)	0.65 mm (+/- 0.1 Al à 100 kV/3.7 mm AI HVL)	Slightly higher attenuation, but likely within an acceptable range for X-ray visibility, especially given overall improvements.
Movement (Table top)	Laterally; longitudinally; 5 way movement: 8 way (Z-motion and tilt)	Laterally; longitudinally; 8-way movement	Similar movement capabilities.
Weight tolerance	265 kg with no restrictions	230 kg	Platinum dRF has a higher weight tolerance, accommodating heavier patients.
Longitudinal movement of table top	150 cm (±75 cm)	160 cm (±80 cm)	Slightly less longitudinal movement than predicate.
Transversal movement of table top	35 cm (±17.5 cm) speed around 6 cm/sec	35 cm (±17.5 cm) speed around 4.5 cm/sec	Equivalent range with faster speed for Platinum dRF.
Patient coverage	201 cm with 2 way, 283 cm with 4 way	Not available	Platinum dRF provides specific patient coverage details, implying improved capability due to larger table.
Focal distance	110 - 180 cm	115 - 150 cm	Platinum dRF offers a wider focal distance range.
Measuring detector/focal point	50 cm	Not available	Platinum dRF provides specific measurement.
Electrical/EMC Testing	Successfully conducted per IEC standards	(Implied by predicate clearance)	Conforms to widely accepted international standards.
Software Validation	Developed, tested, and documented per FDA Guidance (January 2002)	(Implied by predicate clearance)	Demonstrates adherence to FDA software validation guidelines.
Conformity to Standards	IEC 60601-1, -1-2, -1-3, -1-6, -2-54, 62366; NEMA XR7, PS 3.1-3.20; 21 CFR 1020.30, 1020.31, 1020.32	(Implied by predicate clearance)	Conforms to a comprehensive list of international and national standards demonstrating safety and performance.

The study is primarily a substantial equivalence assessment against a predicate device, as detailed in the "Substantial Equivalence Discussion" and "Performance" sections.

Sample size used for the test set and the data provenance:
- The document does not describe a specific "test set" of images or patient cases for direct performance evaluation of the integrated Platinum dRF system.
- Since the system is a platform for already-cleared or registered components, the performance data referenced for these individual components would likely have been generated by their respective manufacturers. The provenance of that data is not specified in this document.
- The submission focuses on the integration of these components and the overall system's physical and technical specifications compared to a predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as a dedicated clinical test set with ground truth established by experts is not described for this 510(k) submission. Performance is inferred through substantial equivalence and compliance with standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as a dedicated clinical test set requiring expert adjudication is not described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study is mentioned.
- This device is an X-ray imaging system, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is an X-ray imaging system. Its "standalone" performance means its ability to produce images and operate according to its specifications.
- The document states: "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."
- This indicates that the performance of the individual imaging components (like the Trixell detector, RALCO collimator, Varian X-ray tube, and CMT Thales Duet imaging software) had been established stand-alone by their respective manufacturers and cleared by the FDA prior to their integration into the Platinum dRF system. The current submission is for the integrated system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the integrated system, the "ground truth" for showing safety and effectiveness relies on:
  - Technical specifications comparison: Demonstrating that key imaging parameters (e.g., image resolution, image speed, dose reduction) are equivalent to or better than the predicate.
  - Compliance with recognized standards: Adherence to IEC (International Electrotechnical Commission) and NEMA (National Electrical Manufacturers Association) standards, as well as FDA regulations (21 CFR 1020, 21 CFR 807.92). These standards ensure basic safety, electrical performance, radiation protection, and electromagnetic compatibility.
  - Prior FDA clearance/registration of components: The individual FDA-cleared components (detector, software) imply their own established performance and "ground truth" from their specific submissions.
The sample size for the training set:
- Not applicable. This is not a machine learning model requiring a training set. The device is a hardware imaging system integrating existing cleared components.
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

Summary

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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.

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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 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 dRFK062623
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 toa vertical axis. automatic lightingon, including positioning camera	Motorized up to a maximum of ±45°. detent at 0°
Field coverage	min 4X4 and max 48X48 at100 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 (solidstate ionization 3 fields)	Not available
X-ray tube	Varian 600 kHU tubes RAD92 andG292: 400 kHU tube RAD60	Self manufactured
Use with X-rayceiling tube	Yes	Yes
X-ray Grid	Smit Röntgen	Self manufactured
Tube motorizedrotation	+180°/-180°	+180/-90°

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	Platinum dRF Imaging System	Siemens AXIOM Luminos dRFK062623

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
detectorAnti-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 dRFK062623
Tablespecifications
Table Tilting	+90°/-90°	+90°/-45° or +90°/-90° (optional)
	Variable tilting up to 10°/sec	Two speeds about 3°/sec and6°/sec.
		Time for complete tilt +90° to 0° :17 sec
	Automatic stop in the 0° position ispossible / angle indication on theremote control panel as well as thepanel on the front of the table.	Automatic stop in the 0° positionis possible / angle indication onthe remote control panel as well asthe panel on the front of the table.
Table top height	50 cm to 130 cm continuouslyadjustable, about 4 cm/sec	50 cm to 100 cm continuouslyadjustable. about 4 cm/sec
	48 cm - 128 cm with the base plate	48 cm - 98 cm with the base platenot encrusted in the floor
Table top	240 x 85 cm / radio transparentfield: 283 x 65 cm / surfaceinalterable / sliding rail system	210 X 80 cm / radio transparentfield : 193 x 53.5 cm / surfaceinalterable / sliding rail system
	Equivalent attenuation value :<0.70 mm (+/- 0.1 Al à 100 kV/3.7mm Al HVL	Equivalent attenuation value : 0.65mm (+/- 0.1 Al à 100 kV/3.7 mmAI HVL
Movement	Laterally; longitudinally5 way movement: 8 way movementincluding Z-motion and tilt motion	Laterally; longitudinally8-way movement
Weight tolerance	265 kg with no restrictions	230 kg
Longitudinalmovement of thetable top(optional)	150 cm (±75 cm)	160cm (±80 cm)
Transversalmovement of thetable top	35 cm (±17.5 cm) speed around 6cm/sec	35 cm (±17.5 cm) speed around4.5 cm/sec
Patient coverage	201 cm with 2 way283 cm with 4 way	Not available
Focal distance	110 - 180 cm	115 - 150 cm
Measuringdetector/focalpoint	50 cm	Not available

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Substantial Equivalence Discussion

The Platinum dRF Imaging System has a similar intended use, the same technology, and uses identical or the same general components as the predicate device. Components and/or component specifications are nearly identical between the Platinum and predicate device. Compared to the predicate device, the Platinum has larger table specifications, larger rotation ability, and greater movement of the AB selector. These differences are designed to allow for larger, taller patients to be examined and for the examinations themselves to conduct. This ability has no impact on the imaging functionality of the device, and does not raise new or different issues of safety or effectiveness. All of the features of the Platinum dRF Imaging System are substantially equivalent to the similar features of the predicate device.

Performance

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.

Software

The system integration and interconnection software was developed. tested and documented in compliance with FDA Guidance "General Principles of Software Validation: Final Guidance for Industry and FDA Staff". January 2002.

Conformity to Standards and 21 CFR 1020.30

The Platinum complies with:

IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) Medical electrical equipment -. Part 1: General requirements for basic safety and essential performance .
IEC 60601-1-3:2008 Medical electrical equipment Part 1-3: General requirements for . basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-1-6 :2010 Medical electrical equipment Part 1-6: General requirements for . basic safety and essential performance - Collateral standard: Usability
IEC 62366: 2007 Medical devices -- Application of usability engineering to medical . devices
IEC 60601-2-54:2009 Medical electrical equipment Part 2-54: Particular requirements . for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

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K131766
Page 6 of 6

1EC 60601-1-2: 2007 Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
NEMA XR7-1995 (R2000) High Voltage X-ray Cable Assemblies and Receptacles (for . the Claymount X-ray Cables)
NEMA PS 3.1-3.20 (2011) Digital Imaging and Communications in Medicine � (DICOM) Set
21 CFR 1020.30. 1020.31 and 1020.32 as applicable .

Conclusion

The Apelem-DMS Platinum dRF Imaging System features are substantially equivalent to the similar features of the Siemens AXIOM Luminos predicate device.

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure embracing a globe or sphere.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 12, 2013

Apelem-DMS Group % Sharyn Orton, Ph.D. Senior Consultant MEDIcept, Inc. 200 Homer Avenue ASHLAND MA 01721

Re: K131766

Trade/Device Name: Platinum dRF Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: October 25, 2013 Received: October 30, 2013

Dear Dr. Orton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device. subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices. good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

{7}------------------------------------------------

Page 2 - Dr. Sharyn Orton

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/McdicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum.

Sincerely yours.

Smh.7)

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K 131766

Device Name

Platinum dRF Imaging System

Indications for Use (Describe)

The Plainum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic sudies. Using a digital flat detector. it cange of applications including general R/F, diagnostic fluoroscopy, conventional linear tomography, angiography and pediatric examinations.

The Plainum 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 gastrointesinal examinations, cranial, shoracic and lung exposures as well as examination of 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

PSU Publishing Services ( 1/2) : 443-6741

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'DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.'

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Regulation Number and Section

§ 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.