Radiology · 510(k) · 2014
YSIO MAX
SIEMENS MEDICAL SOLUTIONS USA, INC.. Cleared by FDA on 24 January 2014 under submission K133259, product code KPR (system, x-ray, stationary). What FDA's record says, in FDA's words.
Device record · K133259
- Device. YSIO MAXDEVICE
- Company. SIEMENS MEDICAL SOLUTIONS USA, INC.COMPANY
- Decision. 24 January 2014, 510(k), substantially equivalent (special review); received 23 October 2013DECISION
- Panel. RadiologyPANEL
- Product code. KPR, System, X-Ray, StationaryCODE
- Regulation. 21 CFR 892.1680, Class IIREG
- Source. FDA database entry · decision document (7 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedradiographs (X-ray)
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1,233 reports filed against devices carrying product code KPR. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Other · SIEMENS MULTIX C · report MW6003180
A patient was not involved in the equipment incident. The technologist was preparing the room for x-ray. He walked up to the overhead lube and was getting ready to move it when the screen flash and went black. The tube then telescoped down about two-three feet and sprung back up to which the technologist heard the locking pin engage. Tech states that the power to the overhead seemed to cut out for a second, the lock released the tube as described, and once it sprung back up, it engaged. Upon […]
16 September 2026 · Malfunction · Radiography 7300 C · Philips Medical Systems DMC GmbH · report 3003768251-2026-100032
28 August 2026 · Malfunction · Radiography 7300 C · Philips Medical Systems DMC GmbH · report 3003768251-2026-100026
28 August 2026 · Malfunction · Radiography 7300 C · Philips Medical Systems DMC GmbH · report 3003768251-2026-100027
It was reported that the Ceiling Suspension (CS) was difficult to move in all directions, including longitudinal and transverse movement. The device was in clinical use and one radiographer reported experiencing muscle and joint strain, particularly in the right shoulder, which was associated with operation of the tube assembly.
28 August 2026 · Malfunction · Radiography 7300 C · Philips Medical Systems DMC GmbH · report 3003768251-2026-100028
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code KPR, in Radiology, from SIEMENS MEDICAL SOLUTIONS USA, INC., or cleared in 2014. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.