DigitalDiagnost C90
Device Facts
| Record ID | K202564 |
|---|---|
| Device Name | DigitalDiagnost C90 |
| Applicant | Philips Medical Systems Dmc GmbH |
| Product Code | MQB · Radiology |
| Decision Date | Sep 30, 2020 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
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 used in clinical settings by healthcare professionals. It consists of a height-adjustable patient table, ceiling-suspended X-ray tube, and vertical stand. The system acquires X-ray images using a fixed flat-panel detector (Pixium 4343RCE) or wireless portable detectors (SkyPlate family, including the new SkyPlate E). The X-ray generator and tube form the image chain. The Eleva Workstation processes, stores, displays, and exports images. The device supports automatic image stitching and detector sharing. Clinicians use the output images for diagnostic assessment. The system benefits patients by providing high-quality digital radiographs for routine and specialized examinations, including trauma and pediatric care.
Clinical Evidence
No clinical data. Substantial equivalence was demonstrated through non-clinical performance testing, including system verification, image quality testing, and human factors/usability engineering, alongside compliance with consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 62220-1, IEC 62304, IEC 60601-1-6, ISO 14971).
Technological Characteristics
Stationary X-ray system; CsI scintillator; TFT readout; 65kW/80kW generator; motorized ceiling suspension and table. Connectivity via Ethernet/WLAN. Software lifecycle per IEC 62304. SkyPlate E detector: 384.5mm x 460.5mm x 16.0mm, 160 μm pixel size, 3.125 lp/mm Nyquist frequency.
Indications for Use
Indicated for routine radiography examinations, including intensive care, trauma, and pediatric patients. Excludes 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
- DigitalDiagnost C90 (K182973)
Reference Devices
- MobileDiagnost wDR 2.2 (K191813)
- Pixium 4343RCE (K170113)
- Eleva Workspot for DigitalDiagnost (K141736)
- Eleva Workspot with SkyFlow (K153318)
Submission Summary (Full Text)
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September 30, 2020
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Philips Medical Systems DMC GmbH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114
## Re: K202564
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: September 2, 2020 Received: September 4, 2020
# Dear Prithul Bom:
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. Although this letter refers to your product as a device, please be aware 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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### 5. Statement of Indication for Use/Intended Use
| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020<br>See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
**Indications for Use**
| 510(k) Number (if known) | K202564 |
|--------------------------------|---------------------|
| 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) | |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
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### K202564
#### 6. 510(k) Summary
### SPECIAL 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: | September 23, 2020 |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Philips Medical Systems DMC GmbH<br>Röntgenstraße 24<br>22335 Hamburg, GERMANY<br>Establishment registration number: 3003768251 |
| Contact Person: | Ming Xiao<br>Regulatory Affairs Manager<br>Phone: +49 40 34971-2306<br>Fax: +49 40 5078-2147<br>E-mail: ming.xiao@philips.com |
| Device Name: | DigitalDiagnost C90 |
| Classification: | |
| | Trade Name: DigitalDiagnost C90 |
| | 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, KPR, LLZ |
| Predicate Device: | |
| | Trade Name: DigitalDiagnost C90 |
| | Manufacturer: Philips Medical Systems DMC GmbH |
| | 510(k) Clearance: K182973- January 11, 2019 |
| | Classification Regulation: 21CFR 892.1680 |
| | Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| | Classification Panel: 90 - Radiology |
| | Device Class: Class II |
| | Product Code: MQB, KPR, LLZ |
| Reference Device for SkyPlate E Detector: | |
| | Trade Name : MobileDiagnost wDR 2.2 |
| | Manufacturer: Sedecal S.A |
| | 510(K) Clearance: K191813- August 2, 2019 |
| Classification Regulation: | 21CFR 892.1720 |
| Classification Name: | Mobile X-ray Systems |
| Classification Panel: | 90- Radiology |
| Device Class: | Class II |
| Product Code: | IZL, MQB |
DigitalDiagnost C90 Premarket Notification – Special 510(k)
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| Device<br>Description | The proposed DigitalDiagnost C90 is same as the 510(K) approved predicate<br>(K182973) as mentioned below | Predicate Device: | Proposed Device: | Discussion & Conclusion | |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | It is a high-end digital radiography system consisting of a height adjustable patient<br>support table and a ceiling suspension consisting of a tube including a control handle<br>used to acquire images with a flat panel fixed RAD detector. Additionally, different<br>vertical stands for the radiography examinations are available. The ceiling suspension<br>can be moved in longitudinal and lateral directions and additionally the tube can be<br>tilted and rotated as well. The proposed DigitalDiagnost C90 is configured with a<br>Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE,<br>together with the tube these components form the radiography Image Chain.<br>The proposed DigitalDiagnost C90 introduces a new wireless portable detector,<br>pixium 3543DR i.e. SkyPlate E (cleared in reference device 510(K) K191813) and<br>their relevant grids, in addition to the family of SkyPlate detectors (pixium 3543EZ<br>i.e. Large and pixium 2430EZ i.e. Small) that are already integrated in the currently<br>marketed (predicate) DigitalDiagnost C90 (K182973). | DigitalDiagnost<br>C90 (K182973-<br>January 11,<br>2019) | DigitalDiagnost<br>C90 (K202564) | | |
| Indications for<br>Use/Intended<br>Use: | The Indication for Use of the proposed DigitalDiagnost C90 is identical to that of the<br>currently marketed and predicate device, DigtalDiagnost C90 (K182973- January 11,<br>2019) and is as follows: | Table Features | | | |
| | The DigitalDiagnost C90 is intended to acquire, process, store, display and export<br>digital radiographic images. The DigitalDiagnost C90 is suitable for all routine<br>radiography examinations, including specialist areas like intensive care, trauma or<br>pediatric work, excluding fluoroscopy, angiography and mammography. | Height adjustable table (TH-2) | | | |
| Fundamental<br>Scientific<br>Technology: | The proposed DigitalDiagnost C90 employs the same basic construction and<br>fundamental scientific technology as the currently marketed predicate DigtalDiagnost<br>C90 (K182973, January 11, 2019), with regards to the functionality of all its<br>components | | | | |
| | The proposed DigitalDiagnost C90 employs the same cleared features as predicate<br>DigitalDiagnost C90 as follows | | | | |
| | fixed RAD detector (Pixium 4343RCE, K170113, February 9, 2017), wireless detectors (SkyPlate Detector, cleared by Eleva Workspot for<br>DigitalDiagnost, K141736, July 25, 2014), image chain acquisition-station and workflow (Eleva Workspot with<br>SkyFlow, K153318, December 22, 2015). | | | | |
| Height<br>adjustment | 51.5 cm to 91.5<br>cm above floor,<br>motorized<br>adjustment | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Table<br>weight | 335 kg | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Max. patient<br>weight | • Static load center:<br>375 kg<br>• Dynamic load<br>center: 318 kg<br>• Dynamic load off<br>center: 210 kg | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Table top<br>Type | Floating table top<br>of sandwich<br>design with<br>Getalit overlay | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Table top<br>Dimension | 240 cm x 75 cm | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Table top<br>travel | • longitudinal: ±56<br>cm<br>• transverse: ±12.8<br>cm,<br>electromagnetic<br>brakes | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Single side suspended table (TH-S) | | | | | |
| Height<br>adjustment | 51 cm to 91 cm<br>motorized<br>adjustment | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Table<br>weight | 214 kg | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Max. patient<br>weight | • table top center:<br>225kg<br>• end of table top:<br>135kg | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Table top<br>Type | Floating table top<br>of sandwich<br>design with<br>Kevlar overlay,<br>flat top | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Table top<br>Dimension | 260 cm x 75 cm | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Thickness of<br>table top | 4.7 cm | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Table top<br>travel | • longitudinal: ±20<br>cm, hydraulic<br>brakes<br>• transverse: ±20<br>cm, hydraulic<br>brakes | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Patient<br>coverage<br>with fixed<br>RAD<br>detector | • longitudinal: 208<br>cm<br>• Transversal: 83<br>cm | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Celling Suspension CSM | | | | | |
| Type | Four-part<br>aluminum<br>telescopic column<br>with spring<br>counter balanced<br>holder for X-ray<br>tube assembly;<br>adaptable to<br>individual room<br>heights | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Ceiling<br>height at<br>source<br>image<br>distance 110<br>cm | 2.83 to 3.21 m | Same | Equivalent; No impact to the<br>safety and effectiveness of the<br>device. | | |
| Movement | 3.26 m to 3.41m | Same | Equivalent; No impact to the<br>safety and effectiveness of the<br>device. | | |
| Transverse<br>travel | 1.49 m to 3.21 m | Same | Equivalent; No impact to the<br>safety and effectiveness of the<br>device. | | |
| Vertical<br>travel | 1.65 m | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| X-ray tube<br>assembly<br>rotation | • around vertical<br>axis: 360° (±180°)<br>with lock position<br>every 45°<br>• around horizontal<br>axis: ±115°, lock | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| | positions 0° and | | | | |
| | ±90° | | | | |
| Length of<br>rails | 4.3 m | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Collimator | • Ralco P 225 ACS<br>DHHS<br>• Motorized<br>automatic<br>collimation<br>• Manual overrule<br>possible<br>• With light field<br>indicator<br>• With 2 Lasers and<br>Camera | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Vertical Stand | | | | | |
| | Vertical moveable stand (VM) | | | | |
| Hardware | Counterbalanced<br>rugged column<br>for motorized<br>vertical<br>movement of the<br>detector unit | Same | Equivalent; No impact to<br>safety and effectiveness of the<br>device. | | |
| Vertical<br>travel | 35 cm to 185 cm…
