DigitalDiagnost C90
Device Facts
| Record ID | K182973 |
|---|---|
| Device Name | DigitalDiagnost C90 |
| Applicant | Philips Medical Systems Dmc GmbH |
| Product Code | MQB · Radiology |
| Decision Date | Jan 11, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.
Device Story
DigitalDiagnost C90 is a stationary digital radiography system comprising a height-adjustable patient table, ceiling-suspended X-ray tube, and fixed flat-panel detector (Pixium 4343RCE). It utilizes a Philips X-ray generator to acquire radiographic images. Operated by clinicians in clinical settings, the system processes, stores, displays, and exports images via the Eleva Workspot interface. The device supports automatic image stitching and includes SkyFlow technology for scatter correction. The system is designed for routine diagnostic imaging; output images are reviewed by healthcare providers to inform clinical decision-making. The device integrates previously cleared components (Eleva Workspot, Pixium detectors, and Bucky Vision architecture) to provide a comprehensive imaging chain.
Clinical Evidence
No clinical data required. Substantial equivalence demonstrated through design features, indications for use, fundamental scientific technology, and non-clinical performance testing, including verification and validation of system integration.
Technological Characteristics
Stationary X-ray system; components include height-adjustable table (sandwich design, Getalit/Kevlar overlay), ceiling suspension (four-part aluminum telescopic column), X-ray tube (Philips SRO 33100), and flat-panel detector (Pixium 4343RCE). Energy source: High-voltage generator (65kW or 80kW). Connectivity: Networked workstation (Eleva Workspot). Standards: ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 6220-1, IEC 62304, IEC 60601-1-6.
Indications for Use
Indicated for routine radiography examinations, including intensive care, trauma, and pediatric applications. Contraindicated for fluoroscopy, angiography, and mammography.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Philips Eleva Workspot for DigitalDiagnost (K141736)
Reference Devices
- Philips Bucky Vision (K982795)
- Eleva Workspot with SkyFlow (K153318)
- Pixium 4343RCE (K170113)
- Ralco P 225 ACS (K091517)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Medical Systems DMC GmbH Ming Xiao Regulatory Affairs Manager Roentgenstrasse 24 Hamburg, 22335 DE GERMANY
January 11, 2019
## Re: K182973
Trade/Device Name: DigitalDiagnost C90 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, KPR, LLZ Dated: October 23, 2018 Received: October 26, 2018
Dear Ming Xiao:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing 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
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara For
Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K182973
Device Name
DigitalDiagnost C90
Indications for Use (Describe)
The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-size:12px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out.
## 7. 510(k) Summary
### 510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
- Date Prepared: revised January 09, 2019
- Manufacturer: Philips Medical Systems DMC GmbH Röntgenstraße 24 22335 Hamburg GERMANY Establishment registration number: 3003768251
- Contact Person: Ming Xiao Regulatory Affairs Manager Phone: +49 40 34971-2306 Fax: +49 40 5078-2425 E-mail: ming.xiao@philips.com
- Device Name: DigitalDiagnost C90
| Classification: | Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) |
|-------------------|---------------------------------------------------------------------------|
| | Classification Regulation: 21CFR 892.1680 |
| | Regulation Description: Stationary x-ray system |
| | Classification Panel: 90 -- Radiology |
| | Device Class: Class II |
| | Classification Product Code: MQB |
| | Secondary Product Codes: KPR, LLZ |
| Predicate Device: | Trade Name: Philips Eleva Workspot for DigitalDiagnost |
| | Manufacturer: Philips Medical System DMC |
| | 510(k) Clearance: K141736 - July 25, 2014 |
| | Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| | Classification Regulation: 21CFR 892.1680 |
| | Classification Panel: 90 -- Radiology |
| | Device Class: Class II |
| | Product code: MQB |
| | Subsequent Product Code: KPR |
DigitalDiagnost C90 Premarket Notification – Traditional 510(k) Page 1 of 13
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image contains the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is plain white, which makes the blue letters stand out.
| Reference | Trade Name: | Philips Bucky Vision | | |
|-------------------------------|-------------------------------------------|---------------------------------------------------------|--|--|
| Device_1 (primary<br>device): | Manufacturer: | Philips Medical System DMC | | |
| | 510(k) Clearance: | K982795 - November 24, 1998 | | |
| | Classification Name: | Solid State X-Ray Imager (Flat<br>Panel/Digital Imager) | | |
| | Classification Regulation: | 21CFR 892.1680 | | |
| | Classification Panel: | 90 -- Radiology | | |
| | Device Class: | Class II | | |
| | Product code:<br>Subsequent Product Code: | MQB<br>KPR | | |
| Reference | Trade Name: | Eleva Workspot with SkyFlow | | |
| Device_2: | Manufacturer: | Philips Medical System DMC | | |
| | 510(k) Clearance: | K153318 - December 22, 2015 | | |
| | Classification Name: | Solid State X-Ray Imager (Flat<br>Panel/Digital Imager) | | |
| | Classification Regulation: | 21CFR 892.1680 | | |
| | Classification Panel: | 90 -- Radiology | | |
| | Device Class: | Class II | | |
| | Product code:<br>Subsequent Product Code: | MQB<br>LLZ | | |
| Reference | Trade Name: | Pixium 4343RCE | | |
| Device_3: | Manufacturer: | Philips Medical System DMC | | |
| | 510(k) Clearance: | K170113 – February 9, 2017 | | |
| | Classification Name: | Solid State X-Ray Imager (Flat<br>Panel/Digital Imager) | | |
| | Classification Regulation: | 21CFR 892.1680 | | |
| | Classification Panel: | 90 -- Radiology | | |
| | Device Class: | Class II | | |
| | Product code: | MOB | | |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill the majority of the frame. The background is plain white, which makes the blue letters stand out.
## Device Description:
The DigitalDiagnost C90 is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The DigitalDiagnost C90 is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE (K170113 - February 9, 2017), together with the tube these components form the radiography Image Chain. As additional options, a portable detector (K141736 - July 25, 2014) can be used for free exposures as well as in the patient support table or in the vertical stand.
The proposed DigitalDiagnost C90 is considered substantially equivalent to the currently marketed and predicate device, Philips Eleva Workspot for DigitalDiagnost (K141736, July 25, 2014), previously designated with primary product code MQB and subsequent product code LLZ, in terms of indications for use and design characteristics. Nevertheless product code KPR -being also considered substantially equivalent- (based upon submission Philips Bucky Vision (K982795, November 24, 1998) is chosen for this new submission, because it refers back to a complete "stationary x-ray system".
The proposed DigitalDiagnost C90 incorporates the following features, previously cleared by FDA in the following reference devices:
| Design Feature/ Attribute | Currently Marketed and Reference Device - Philips Medical Systems |
|---------------------------------------------------------------|-------------------------------------------------------------------|
| Primary device | Philips Bucky Vision (K982795, November 24, 1998) |
| Image Chain acquisition-station and workflow (Eleva Workspot) | Eleva Workspot with SkyFlow (K153318, December 22, 2015) |
| Fixed static detector | Pixium RCE (K170113, February 9, 2017) |
The Indications for Use for the proposed DigitalDiagnost C90 are as follows:
The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white.
# Device History / Predicate Device for DigitalDiagnost C90:
| 510(k) | Decision<br>Date | Cleared<br>Device | Product<br>Code | Predicate<br>Device | Intended Use | Release Product |
|---------|------------------|-----------------------------------------------------------------------|-----------------|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| K982795 | 24.11.1998 | Philips<br>Bucky<br>Vision | MQB, KPR | K945278 | The Philips<br>BuckyVision is<br>intended for use<br>in general radio-<br>graphic exam-<br>inations and<br>applications<br>wherever con-<br>ventional<br>screen-film<br>system may be<br>used (excluding<br>fluoroscopy,<br>angiography<br>and mammo-<br>graphy). | DigitalDiagnost<br>Release 1 (issued<br>as Bucky Vision<br>for cleared<br>510(k)<br>declaration<br>K982795 in<br>1998) |
| K063781 | 05.01.2007 | Philips XD-<br>S Direct<br>Radiograph<br>y<br>Workstatio<br>n/Package | LLZ, MQB | K982795 | As part of a<br>radiographic<br>system, the<br>Philips XD-S<br>is intended to<br>acquire,<br>process, store,<br>display and<br>export digital<br>radiographic<br>images. The<br>Philips XD-S is<br>suitable for all<br>routine radio-<br>graphy exams,<br>including<br>specialist areas<br>like intensive<br>care, trauma, or<br>pediatric work,<br>excluding<br>mammography. | DigitalDiagnost<br>Release 2 |
| K090625 | 24.03.2009 | Wireless<br>Portable<br>Detector<br>FD-W17 | MQB | K982795<br>K063781 | As part of a<br>radiographic<br>system, the<br>Wireless<br>Portable<br>Detector FD-<br>W17 is intended<br>to acquire<br>digital radio-<br>graphic images.<br>The Wireless<br>Portable | DigitalDiagnost<br>Release 3 |
| 510(k) | Decision<br>Date | Cleared<br>Device | Product<br>Code | Predicate<br>Device | Intended Use | Release Product |
| | | | | | Detector FD-<br>W17 is suitable<br>for all routine<br>radiography<br>exams,<br>including<br>specialist areas<br>like intensive<br>care, trauma, or<br>pediatric work,<br>excluding<br>fluoroscopy,<br>angiography<br>and mammo-<br>graphy. | |
| K131483 | 07.10.2013 | Philips<br>Pixium<br>4343RC | MQB | K982795<br>K063781<br>K090625 | As part of a<br>radiographic<br>system, the<br>Philips Pixium<br>4343RC is<br>intended to<br>acquire digital<br>radiographic<br>images. The<br>Philips Pixium<br>4343RC is<br>suitable for all<br>routine radio-<br>graphy exams,<br>including<br>specialist areas<br>like intensive<br>care, trauma, or<br>pediatric work,<br>excluding<br>fluoroscopy,<br>angiography<br>and<br>mammography. | DigitalDiagnost<br>Release 4 |
| K141736 | 25.07.2014 | Philips<br>Eleva<br>Workspot<br>for<br>DigitalDiag<br>nost | MQB, LLZ | K090625 | As part of a<br>radiographic<br>system, the<br>Philips Eleva<br>Workspot with<br>SkyPlate<br>Detectors is<br>intended to<br>acquire,<br>process, store,<br>display and<br>export digital<br>radiographic | DigitalDiagnost<br>Release 4 with<br>SkyPlate<br>Detectors |
| 510(k) | Decision Date | Cleared Device | Product Code | Predicate Device | Intended Use | Release Product |
| K18xxxx | | DigitalDiagnost C90 | MQB, LLZ, KPR | K141736 | images. The Philips Eleva Workspot with SkyPlate Detectors is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.<br>The Digital-Diagnost C90 is intended to acquire, process, store, display and export digital radio-graphic images. The Digital-Diagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography | DigitalDiagnost C90 |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out.
## Fundamental Scientific Technology:
The DigitalDiagnost C90 employs the same basic construction and fundamental scientific technology as the currently marketed and predicate Philips Eleva Workspot for DigitalDiagnost (K141736, July 25, 2014), with regards to the functionality of the following components: table, system-control, X-Ray tube, detector, and generator etc. (see the comparison table comparing
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.
the DigitalDiagnost C90 to the currently marketed and predicate Philips Eleva Workspot for DigitalDiagnost provided below).
The DigitalDiagnost C90 employs the following cleared features: fixed RAD detector (Pixium 4343RCE, K170113, February 9, 2017), wireless detectors (SkyPlate Detector, cleared by Eleva Workspot for DigitalDiagnost, K141736, July 25, 2014)) and the image chain acquisition-station and workflow (Eleva Workspot with SkyFlow, K153318, December 22, 2015). The fixed detector, wireless portable detectors, and the image chain and workstation of the DigitalDiagnost C90 are identical to the fixed detector, wireless portable detectors, and the image chain and workstation of the currently marketed and reference devices. Therefore, the fixed detector, wireless portable detectors, and the image chain and workstation employ identical fundamental scientific technology.
The outcome of this comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of the DigitalDiagnost C90 when compared to the currently marketed and predicate Philips Eleva Workspot for DigitalDiagnost.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out.
#### Summary of technological characteristics: .
The DigitalDiagnost C90 has similar indications for use and technological characteristics as the predicate device, Philips Eleva Workspot for DigitalDiagnost. Comparisons of the technological characteristics demonstrate the substantial equivalence to the predicate device.
| | Predicate Device:<br>Philips Eleva Workspot<br>for DigitalDiagnost<br>Release 4 with SkyPlate<br>Detectors / (K141736) | Proposed Device:<br>DigitalDiagnost C90<br>(K18xxxx) | Discussion & Conclusion |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Table Features | | | |
| Height adjustable table (TH) | | | |
| Height adjustment | 51.5 cm to 91.5 cm<br>above floor, motorized<br>adjustment | 51.5 cm to 91.5 cm<br>above floor, motorized<br>adjustment | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Table weight | 335 kg | 335 kg | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Max. patient<br>weight | Static load center: 375<br>kg<br>Dynamic load center:<br>318 kg<br>Dynamic load off center:<br>210 kg | Static load center: 375<br>kg<br>Dynamic load center:<br>318 kg<br>Dynamic load off<br>center: 210 kg | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Table top Type | Floating table top of<br>sandwich design with<br>Getalit overlay | Floating table top of<br>sandwich design with<br>Getalit overlay | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Table top<br>Dimension | 240 cm x 75 cm | 240 cm x 75 cm | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Table top travel | • longitudinal: ±60 cm<br>• transverse: ±13 cm,<br>electromagnetic<br>brakes | • longitudinal: ±60<br>cm<br>• transverse: ±12 cm,<br>electromagnetic<br>brakes | Similar: Minor differences<br>in the table top travel does<br>not affect the safety or<br>effectiveness of the device. |
| Single side suspended table (TH-S) | | | |
| Height adjustment | 50.3 cm to 90.3 cm<br>motorized adjustment | 50.3 cm to 90.3 cm<br>motorized adjustment | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Table weight | 214 kg | 214 kg | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Max. patient<br>weight | 225 kg | •table top center: 225<br>kg<br>•end of table top: 135<br>kg | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Table top Type | Floating table top of<br>sandwich design with<br>Kevlar overlay, flat top | Floating table top of<br>sandwich design with<br>Kevlar overlay, flat<br>top | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| | Predicate Device:<br>Philips Eleva Workspot<br>for DigitalDiagnost<br>Release 4 with SkyPlate<br>Detectors / (K141736) | Proposed Device:<br>DigitalDiagnost C90<br>(K18xxxx) | Discussion & Conclusion |
| Table top<br>Dimension | 260 cm x 75 cm | 260 cm x 75 cm | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Thickness of table<br>top | 4.7 cm | 4.7 cm | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Table top travel | • longitudinal: ±20 cm,<br>hydraulic brakes<br>• transverse: ±20 cm,<br>hydraulic brakes | • longitudinal: ±20<br>cm, hydraulic<br>brakes<br>• transverse: ±20 cm,<br>hydraulic brakes | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Patient coverage<br>with fixed RAD<br>detector | • longitudinal: 208 cm<br>• Transversal: 83 cm | • longitudinal: 208<br>cm<br>• Transversal: 83 cm | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Celling Suspension CSM | | | |
| Type | Four-part aluminum<br>telescopic column with<br>spring counter balanced<br>holder for X-ray tube<br>assembly; adaptable to<br>individual room heights | Four-part aluminum<br>telescopic column with<br>spring counter<br>balanced holder for X-<br>ray tube assembly;<br>adaptable to individual<br>room heights | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Ceiling height at<br>source image<br>distance 110 cm | 2.83 m to 3.21 m | 2.65 m to 3.20 m | Similar: Minor differences<br>in the Ceiling height does<br>not affect the safety or<br>effectiveness of the device. |
| Movement | 3.28 m to 3.44 m | 3.28 m to 3.44 m | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Transverse travel | 1.50 m to 3.22 m | 1.49 m to 3.21 m | Similar: Minor differences<br>in the Transverse travel do<br>not affect the safety or<br>effectiveness of the device. |
| Vertical travel | 1.65 m | 1.65 m | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| X-ray tube<br>assembly rotation | • around vertical axis:<br>360° (±180°) with<br>lock position every<br>45°<br>• around horizontal<br>axis: ±125°, lock<br>positions 0° and ±90° | • around vertical axis:<br>360° (±180°) with<br>lock position every<br>45°<br>• around horizontal<br>axis: ±125°, lock<br>positions 0° and<br>±90° | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| | Predicate Device:<br>Philips Eleva Workspot<br>for DigitalDiagnost<br>Release 4 with SkyPlate<br>Detectors / (K141736) | Proposed Device:<br>DigitalDiagnost C90<br>(K18xxxx) | Discussion & Conclusion |
| Length of rails | 4.3 m | 4.3 m | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Collimator | • Ralco P 225 ACS<br>DHHS<br>• Motorized automatic<br>collimation<br>• Manual overrule<br>possible<br>• With light field<br>indicator | • Ralco P 225 ACS<br>DHHS<br>• Motorized auto-<br>matic collimation<br>• Manual overrule<br>possible<br>• With light field<br>indicator<br>• With 2 Lasers and<br>Camera | Ralco Collimator R225<br>ACS is cleared by Ralco<br>K091517 (on 14, July<br>2009), Ralco P 225 ACS<br>DHHS is cleared by Letter<br>to File on 02, February<br>2016 based on K091517.<br>Laser and Camera are<br>already certified and cleared<br>as options in K091517.<br>Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| | Vertical Stand<br>Vertical moveable stand (VM) | | |
| Hardware | Counterbalanced rugged<br>column for motorized<br>vertical movement of the<br>detector unit | Counterbalanced<br>rugged column for<br>motorized vertical<br>movement of the<br>detector unit | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Vertical travel | 35 cm to 185 cm | 35 cm to 185 cm | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Horizontal travel | • Motorized: 3.475 m<br>• non-motorized: 3.71 m<br>• with extension rails,<br>motorized: 5.5 m<br>• with extension rails,<br>non-motorized: 5.5 m | • Motorized: 3.475 m<br>• with extension rails,<br>motorized: 5.5 m | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Swiveling range | 0° to 90° (right or left<br>orientated execution) | 0° to 90° (right or left<br>orientated execution) | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Lock-in positions | manual or every 15° | manual or every 15° | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| | Fixed Vertical Stand (VS) | | |
| Hardware | Counterbalanced rugged<br>column for motorized<br>and manual vertical<br>movement of the detector | Counterbalanced<br>rugged column for<br>motorized and manual<br>vertical movement of<br>the detector | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| Vertical travel | 30 cm to 180 cm | 30 cm to 180 cm | Equivalent; No impact to<br>safety or effectiveness of<br>the device. |
| | Predicate Device:<br>Philips Eleva Workspot<br>for DigitalDiagnost<br>Release 4 with SkyPlate<br>Detectors / (K141736) | Proposed Device:<br>DigitalDiagnost C90<br>(K18xxxx) | Discussion & Conclusion |
| Installation | Floor and wall attachment or floor only | Floor and wall attachment or floor only | Equivalent; No impact to safety or effectiveness of the device. |
| Fixed RAD<br>Detector | Pixium 4343RC | Pixium 4343RCE | The proposed<br>DigitalDiagnost C90<br>includes the fixed RAD<br>detector Pixium 4343RCE<br>used in the currently<br>marketed and reference<br>device, Pixium 4343 RCE<br>(K170113). Therefore,<br>there is no impact on the<br>safety or effectiveness of<br>the device. |
| Wireless Static<br>Detector | SkyPlate Detector family | SkyPlate Detector<br>family | Equivalent; No impact to safety or effectiveness of the device. |
| Generator | High-voltage generator 65kW or 80kW | High-voltage generator 65kW or 80kW | Equivalent; No impact to safety or effectiveness of the device. |
| Tube | High power X-ray Tube, Philips SRO 33100 | High power X-ray<br>Tube, Philips SRO<br>33100 | Equivalent; No impact to safety or effectiveness of the device. |
| SkyFlow | No | Yes | The proposed<br>DigitalDiagnost C90<br>includes the SkyFlow used<br>in the currently marketed<br>and reference device Eleva<br>Workspot with SkyFlow,<br>(K153318). Therefore,<br>there is no impact on the<br>safety or effectiveness of<br>the device. |
| Eleva Workspot | Yes | Yes | Equivalent; No impact to safety or effectiveness of the device. |
| SkyPlate Detector<br>Sharing | Yes | Yes | Equivalent; No impact to safety or effectiveness of the device. |
| Automatic Image<br>stitching | Yes | Yes | Equivalent; No impact to safety or effectiveness of the device. |
| Indications for Use | As part of a radiographic<br>system, the Philips Eleva<br>Workspot with SkyPlate<br>Detectors is intended to<br>acquire, process, store,<br>display and export | The DigitalDiagnost<br>C90 is intended to<br>acquire, process.<br>store, display and<br>export digital radio-<br>graphic images. The | Equivalent; The Indications<br>for Use for the proposed<br>DigitalDiagnost C90 is<br>more general in nature and<br>exactly the same as the<br>currently marketed and |
| Predicate Device:<br>Philips Eleva Workspot<br>for DigitalDiagnost<br>Release…
