Who is the manufacturer of DDRVERSA MOTION?

Swissray Medical AG filed the 510(k) submission for DDRVERSA MOTION (K123005).

What is the FDA product code for DDRVERSA MOTION?

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

What is the regulatory pathway for DDRVERSA MOTION?

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

What are the predicate devices for DDRVERSA MOTION?

ddRElement™ (K110828); Suinsa (K083109).

Who can help prepare an FDA 510(k) submission like DDRVERSA MOTION?

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.

DDRVERSA MOTION

K123005 · Swissray Medical AG · MQB · Dec 7, 2012 · Radiology

Device Facts

Record ID	K123005
Device Name	DDRVERSA MOTION
Applicant	Swissray Medical AG
Product Code	MQB · Radiology
Decision Date	Dec 7, 2012
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1680
Device Class	Class 2

Intended Use

The ddR Versa™ Motion System is intended for use by a qualified/trained doctor or technician on subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)

Device Story

Digital diagnostic X-ray system; captures radiographic images of skull, spine, chest, abdomen, and extremities. System utilizes ceiling-mounted X-ray tube and two digital X-ray receptor panels (wall-mounted and table-mounted). Operates via Windows-based workstation with touch-screen monitor, keyboard, and mouse. Used in clinical settings by qualified doctors or technicians. Transforms X-ray energy into digital images using A-Si TFT flat panel detectors with Cesium iodide scintillators. Output provides diagnostic-quality images for clinical review and decision-making. Benefits include improved workflow through motorized table, automatic positioning, and dual-panel configuration.

Clinical Evidence

Clinical images were obtained per FDA Guidance Document on Solid State Imaging Devices. Images were compared to predicate device images and evaluated by professional radiologists, who confirmed good diagnostic quality. No quantitative metrics (e.g., sensitivity/specificity) were reported.

Technological Characteristics

Digital X-ray system; high-frequency generator (64kW or 80kW); Trixell 4343 RC or Pixium Portable 3543 EZ A-Si TFT flat panel detectors with Cesium iodide (CsI) scintillator; 16-bit A/D conversion; 148 μm pixel size; 2880 x 2880 pixel matrix; 40-150 kVp energy range. Motorized table; ceiling-mounted tube support. Connectivity via Windows workstation. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients requiring diagnostic radiographic imaging of the skull, spine, chest, abdomen, and extremities. Suitable for patients in sitting, standing, prone, or supine positions. Contraindicated for 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

ddRElement™ (K110828)
Suinsa (K083109)

Related Devices

K091752 — VIZTEK WL · Viztek, Inc. · Nov 12, 2009
K140683 — 0180 INTUITION, 0072 PRECISION · Arcoma AB · Jun 3, 2014
K212291 — PHOENIX · Sedecal., Sa. · Sep 14, 2021
K190601 — MasteRad MX30 · Medicatech USA · Apr 25, 2019
K162971 — Multix Fusion Max · Siemens Medical Solutions USA, Inc. · Nov 22, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ ## 510(k) Summary: K123005 - 1. Submitter: Swissray Medical AG Turbistrasse 25 - 27 CH-6280 Hochdorf Switzerland Phone +41 41 914 12 12 Fax +41 41 914 12 13 Date Prepared: November 13, 2012 Contact: Markus Bütler, Quality Manager - Identification of the Device: ddRVersa™ Motion (Digital Diagnostic X-Ray System); 2. Recommended classification regulation: 21 CFR 892.1650, 892.1680 Device class: II, Panel: Radiology, Product code: MQB and KPR - Predicate Device: This is a MODIFICATION to ddRElement™ under document number K110828 and 3. Suinsa (Now owned by Sedecal) (K083109). - 4. A description of the device: ddRVersa™ Motion uses the same core technology as our ddRElement but is modified in that: The supplier for the digital x-ray receptor panel has changed. The system can now accommodate two digital x-ray receptor panels instead of just one. A Wi-Fi digital x-ray receptor panel may be chosen as the second panel. The tubestand is changed from a C-arm configuration to an overhead plus wall stand configuration. The table is changed from non-motorized to motorized. The generator supplier has been changed. The collimator has been changed. (See comparison table below) - 5. Intended for use by a qualified/trained doctor or technician on Intended use of the device: subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography) (SAME as predicate) - The ddRVersa™ Motion has essentially the same technological characteristics (i.e., design, material, 6. chemical composition, energy source) as the predicate device ddRElement™. See the comparison table below. There are really only two main differences: The tubehead is now an overhead version and the system can now accommodate two digital panels. The panel resolution and technology remains the same. ### Comparison Table | Characteristic | Suinsa (Now owned by Sedecal) (K083109) | Swissray ddRElement™ (K110828) | Swissray ddRVersa™ Motion (K123005) (New modified device) | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Overall Configuration | Image: Suinsa (Now owned by Sedecal) (K083109) | Image: Swissray ddRElement™ (K110828) | Image: Swissray ddRVersa™ Motion (K123005) (New modified device) | | Characteristic | Suinsa (Now owned by Sedecal) (K083109) | Swissray ddRElement™ (K110828) | Swissray ddRVersa™ Motion (K123005) (New modified device) | | Intended Use | General purpose radiography except not for mammography | SAME | SAME | | Control System: Positioning | Software Driven with Touch Panel LCD (Sedecal product) | Manual | Software Driven via Windows workstation with touch-screen monitor, keyboard, and mouse | | Control System: Exposure | Software Driven with Touch Panel LCD (Sedecal product) | Software Driven via Windows workstation with touch-screen monitor, keyboard, and mouse (Samsung LTX240AA01-A, K090742) | Software Driven via Windows workstation with touch-screen monitor, keyboard, and mouse (Pixium 4343 RC or Portable 3543 EZ) | | Configuration: Tube | Ceiling-mounted single tube; automatic positioning (utilizing Sedecal Nova FA X- Ray tube overhead support system) | Single tube column- mounted on U-Arm with detector; manual positioning | SAME AS SEDECAL Ceiling-mounted single tube; automatic positioning (utilizing Sedecal Nova FA X- Ray tube overhead support system) | | Configuration: Detector/Image Receptor | Not applicable | One detector system: Column-mounted U-Arm with tube with Samsung LTX240AA01-A panel (K090742) | Two detector system: Wall- mounted (column) and Table-mounted | | Receptor Details | Not applicable | Technology Single A-Si TFT + photodiode plate Cesium iodide scintillator (Csl) A/D conversion 14 bit Active detector area 43 cm x 43 cm Spatial resolution 3.0 lp/mm Active pixel matrix 3072 x 3072 pixels Pixel size 143 μm Energy range 40-150 kVp Sensitivity > 120 LSB/μGy | Technology Single A-Si TFT + photodiode plate Cesium iodide scintillator (Csl) A/D conversion 16 bit Active detector area 43 cm x 43 cm Spatial resolution 3.5 lp/mm Active pixel matrix Active pixel matrix 2880 x 2880 pixels Pixel size 148 μm Energy range 40- 150 kVp Sensitivity up to 850 LSB/μGy | | Generator: Type | High frequency made by Sedecal | CPI Canada CMP200 high frequency generator | High Frequency SHF 635/645 or SHF 835/845 made by Sedecal | | Generator: Capacity | 30 kW to 64 kW | 65 - 80 kW | 64kW or 80kW | | Characteristic | Suinsa (Now owned by Sedecal) (K083109) | Swissray ddRElement™ (K110828) | Swissray ddRVersa™ Motion (K123005) (New modified device) | | Detector/Image Receptor: Resolution | Not applicable | Samsung LTX240AA01-A (K090742) | Trixell 4343 RC a-si TFT flat panel or Pixium Portable 3543 EZ : 148 microns pixel size, with 2880 x 2880 pixels (8.2 mil pixels) 16 bit | | Tube: Type | Toshiba 7869x 0.6/1.2 | Dunlee DR1436CRSR | Toshiba 7869x 0.6/1.2 | | Tube: Capacity | 150KV | 150KV | 150KV | | Collimator + cu filter | Huestis | Siemens ML02 | Ralco 225 43x43cm Motorized filters 1mm AL +0.1mm Cu 1mm AL +0.2mm Cu 2mm AL | | Energy Source: | 120V, 230/240 V 50/60 Hz | SAME | SAME | | Performance Standard | 21 CFR 1020.30 | SAME | SAME | | Electrical Safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | | EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | DEC 7 2012 {1}------------------------------------------------ : . : {2}------------------------------------------------ - 7. Description of non-clinical tests. The modified unit has undergone electrical safety and electromagnetic compatibility testing, as well as software validation and risk analysis. The technical characteristics of the new panel have been measured and included in the bench testing information. - 8. Description of clinical tests. Clinical images were obtained in accordance with the FDA Guidance Document on Solid State Imaging Devices. They were compared to our predicate images and evaluated by professional radiologists and found to be of good diagnostic quality. - 9. Conclusions drawn: The nonclinical and clinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph 3, above. {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem is a graphic representation of an eagle or bird-like figure, with three curved lines forming its body and wings. The overall design is simple and recognizable, representing the department's role in health and human services. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 December 7, 2012 Swissray Medical AG % Mr. Daniel Kamm, P.E. Submission Correspondent Kamm & Associates 8870 Ravello Ct NAPLES FL 34113 Re: K123005 Trade/Device Name: ddRVersa™ Motion Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: November 16, 2012 Received: November 20, 2012 Dear Mr. Kamm: 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, 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 (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. {4}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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/Resourcesfor You/Industry/default.htm. Sincerely yours. Michael D. O'Hara Janine M. Morris, M.S. Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): K123005 Device Name: ddRVersa™ Motion Indications for Use: The ddR Versa™ Motion System is intended for use by a qualified/trained doctor or technician on subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography) Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Michael D. O'Hara (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) K123005 Page 1 of