Who is the manufacturer of DigitalDiagnost C90?

Philips Medical Systems Dmc GmbH filed the 510(k) submission for DigitalDiagnost C90 (K202564).

What is the FDA product code for DigitalDiagnost C90?

MQB. It is classified under 21 CFR 892.1680 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for DigitalDiagnost C90?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like DigitalDiagnost C90?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DigitalDiagnost C90

K202564 · Philips Medical Systems Dmc GmbH · MQB · Sep 30, 2020 · Radiology

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

Intended 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)

Related Devices

K182973 — DigitalDiagnost C90 · Philips Medical Systems Dmc GmbH · Jan 11, 2019
K210692 — DigitalDiagnost · Philips Medical Systems Dmc GmbH · Apr 2, 2021
K173433 — ProxiDiagnost N90 · Philips Medical Systems Dmc GmbH · Feb 5, 2018
K201725 — DigitalDiagnost C50 · Philips Healthcare (Suzhou) Co., Lit. · Jul 10, 2020
K223060 — DigiX FDX · Allengers Medical Systems Limited · Oct 26, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ September 30, 2020 Image /page/0/Picture/1 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "PHILIPS" in a sans-serif font. The letters are a light blue color. The word is written in all capital letters and is centered in the image. The background is white. ### 5. Statement of Indication for Use/Intended Use | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 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> | 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." FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are sans-serif and evenly spaced. The background is plain white, which makes the blue letters stand out. ### 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 Röntgenstraße 24 22335 Hamburg, GERMANY Establishment registration number: 3003768251 | | Contact Person: | Ming Xiao Regulatory Affairs Manager Phone: +49 40 34971-2306 Fax: +49 40 5078-2147 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) {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is plain white, which makes the blue letters stand out. | Device Description | The proposed DigitalDiagnost C90 is same as the 510(K) approved predicate (K182973) as mentioned below | Predicate Device: | Proposed Device: | Discussion & Conclusion | | |-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | It 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 proposed DigitalDiagnost C90 is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE, together with the tube these components form the radiography Image Chain. The proposed DigitalDiagnost C90 introduces a new wireless portable detector, pixium 3543DR i.e. SkyPlate E (cleared in reference device 510(K) K191813) and their relevant grids, in addition to the family of SkyPlate detectors (pixium 3543EZ i.e. Large and pixium 2430EZ i.e. Small) that are already integrated in the currently marketed (predicate) DigitalDiagnost C90 (K182973). | DigitalDiagnost C90 (K182973- January 11, 2019) | DigitalDiagnost C90 (K202564) | | | | Indications for Use/Intended Use: | The Indication for Use of the proposed DigitalDiagnost C90 is identical to that of the currently marketed and predicate device, DigtalDiagnost C90 (K182973- January 11, 2019) and is as follows: | Table Features | | | | | | 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. | Height adjustable table (TH-2) | | | | | Fundamental Scientific Technology: | The proposed DigitalDiagnost C90 employs the same basic construction and fundamental scientific technology as the currently marketed predicate DigtalDiagnost C90 (K182973, January 11, 2019), with regards to the functionality of all its components | | | | | | | The proposed DigitalDiagnost C90 employs the same cleared features as predicate DigitalDiagnost C90 as follows | | | | | | | fixed RAD detector (Pixium 4343RCE, K170113, February 9, 2017), wireless detectors (SkyPlate Detector, cleared by Eleva Workspot for DigitalDiagnost, K141736, July 25, 2014), image chain acquisition-station and workflow (Eleva Workspot with SkyFlow, K153318, December 22, 2015). | | | | | | Height adjustment | 51.5 cm to 91.5 cm above floor, motorized adjustment | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Table weight | 335 kg | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Max. patient weight | • Static load center: 375 kg • Dynamic load center: 318 kg • Dynamic load off center: 210 kg | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Table top Type | Floating table top of sandwich design with Getalit overlay | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Table top Dimension | 240 cm x 75 cm | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Table top travel | • longitudinal: ±56 cm • transverse: ±12.8 cm, electromagnetic brakes | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Single side suspended table (TH-S) | | | | | | | Height adjustment | 51 cm to 91 cm motorized adjustment | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Table weight | 214 kg | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Max. patient weight | • table top center: 225kg • end of table top: 135kg | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Table top Type | Floating table top of sandwich design with Kevlar overlay, flat top | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Table top Dimension | 260 cm x 75 cm | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Thickness of table top | 4.7 cm | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Table top travel | • longitudinal: ±20 cm, hydraulic brakes • transverse: ±20 cm, hydraulic brakes | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Patient coverage with fixed RAD detector | • longitudinal: 208 cm • Transversal: 83 cm | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Celling Suspension CSM | | | | | | | Type | Four-part aluminum telescopic column with spring counter balanced holder for X-ray tube assembly; adaptable to individual room heights | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Ceiling height at source image distance 110 cm | 2.83 to 3.21 m | Same | Equivalent; No impact to the safety and effectiveness of the device. | | | | Movement | 3.26 m to 3.41m | Same | Equivalent; No impact to the safety and effectiveness of the device. | | | | Transverse travel | 1.49 m to 3.21 m | Same | Equivalent; No impact to the safety and effectiveness of the device. | | | | Vertical travel | 1.65 m | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | X-ray tube assembly rotation | • around vertical axis: 360° (±180°) with lock position every 45° • around horizontal axis: ±115°, lock | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | | positions 0° and | | | | | | | ±90° | | | | | | Length of rails | 4.3 m | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Collimator | • Ralco P 225 ACS DHHS • Motorized automatic collimation • Manual overrule possible • With light field indicator • With 2 Lasers and Camera | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Vertical Stand | | | | | | | | Vertical moveable stand (VM) | | | | | | Hardware | Counterbalanced rugged column for motorized vertical movement of the detector unit | Same | Equivalent; No impact to safety and effectiveness of the device. | | | | Vertical travel | 35 cm to 185 cm…