Radiology · 510(k) · 2022
Micro C Medical Imaging System, M01
OXOS Medical, Inc.. Cleared by FDA on 4 February 2022 under submission K212654, product code IZL (system, x-ray, mobile). What FDA's record says, in FDA's words.
Device record · K212654
- Device. Micro C Medical Imaging System, M01DEVICE
- Company. OXOS Medical, Inc.COMPANY
- Decision. 4 February 2022, 510(k), substantially equivalent (traditional review); received 23 August 2021DECISION
- Panel. RadiologyPANEL
- Product code. IZL, System, X-Ray, MobileCODE
- Regulation. 21 CFR 892.1720, Class IIREG
- Source. FDA database entry · decision document (11 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 Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult and pediatric patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types.
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)
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsa diagnostic claim
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 929 reports filed against devices carrying product code IZL. 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:
29 September 2026 · Malfunction · Raidography 7000 M · Philips Medical Systems DMC GmbH · report 3003768251-2026-100039
24 September 2026 · Malfunction · Raidography 7000 M · Philips Medical Systems DMC GmbH · report 3003768251-2026-100036
It was reported that the system stopped driving after completion of a patient examination. After rebooting the system, it would only drive in reverse at full speed. The device was out of clinical use, and there was no patient or user harmed.
4 September 2026 · Injury · MOBILETT Elara Max · Siemens Healthineers AG · report 3004977335-2026-00156
Siemens Healthineers (Siemens) was notified of an event involving an MOBILETT Elara Max system. It was communicated that a member of the hospital staff sustained an electrical shock when they plugged the system in. The person was admitted to the emergency room for examination; however, details regarding the clinical outcome are unknown to Siemens as of the date of this report. This information has been requested by Siemens.
2 September 2026 · Other · MOBILE X-RAY SYSTEM · report MW6001712
On (b)(6) 2026, (b)(6) received information regarding an event that occurred the same day at (b)(6) , Spain, involving a Siemens Mobilett mobile x-ray system. According to the Field Service Engineer (FSE), while removing the monoblock assembly, the support arm was manually lowered to facilitate access to the x-ray tube. After the x-ray tube was uncoupled from the arm, the reduction in load caused the arm to rapidly return upward and strike the FSE in the face. As a result, the FSE sustained an […]
24 August 2026 · Malfunction · Portable X-Ray · UNKNOWN · report MW6001420
Lead acid battery on a portable x-ray machine began to smoke while it was chargingand filled a hospital hallway with smoke.
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 IZL, in Radiology, or cleared in 2022. 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.