Radiology · 510(k) · 2026
BIOGRAPH One
Siemens Healthineers AG. Cleared by FDA on 15 January 2026 under submission K253023, product code OUO (tomographic imager combining emission computed tomography with nuclear magnetic resonance). What FDA's record says, in FDA's words.
Device record · K253023
- Device. BIOGRAPH OneDEVICE
- Company. Siemens Healthineers AG (DE)COMPANY
- Decision. 15 January 2026, 510(k), substantially equivalent (traditional review); received 19 September 2025DECISION
- Panel. RadiologyPANEL
- Product code. OUO, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic ResonanceCODE
- Regulation. 21 CFR 892.1200, Class IIREG
- Source. FDA database entry · decision document (18 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.
Magnetic Resonance Imaging (MRI) is a noninvasive technique used for diagnostic imaging. MRI with its soft tissue contrast capability enables the healthcare professional to differentiate between various soft tissues, for example, fat, water, and muscle, but can also visualize bone structures. Depending on the region of interest, contrast agents may be used. The MR system may also be used for imaging during interventional procedures and radiation therapy planning. The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders, and cancer. The integrated system utilizes the MRI for radiation-free attenuation correction maps for PET studies. The integrated system provides inherent anatomical reference for the fused MR and PET images due to precisely aligned MR and PET image coordinate systems.
The product code's definition, from FDA's classification record. Imager that generates both both magnetic resonance (mr) and positron emission tomography (pet) images and provides registration and fusion of these images. Pet and mr images can be acquired either simultaneously or sequentially. Anatomical mr images are used for pet attenuation correction.
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 namedMRI
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 13 reports filed against devices carrying product code OUO. 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:
15 April 2026 · Injury · NA · GE MEDICAL SYSTEMS, LLC · report 2183553-2026-00002
AFTER COMPLETION OF AN EXAM, A TECHNOLOGIST TRIPPED OVER TUBING FROM THE PATIENT ALERT BALL THAT HAD EXTENDED ONTO THE SCAN ROOM FLOOR WHILE THE PATIENT WAS REMOVED FROM THE BORE OF THE SCANNER. THE TECHNOLOGIST FELL, LANDING ON THE RIGHT KNEE, STRIKING THE NOSE, AND INJURING THE LEFT SHOULDER WHILE ATTEMPTING TO BRACE THE FALL. THE TECHNOLOGIST SOUGHT MEDICAL EVALUATION AT AN URGENT CARE FACILITY THE FOLLOWING DAY AND WAS DIAGNOSED WITH A LEFT CHEST CONTUSION AND LEFT SHOULDER STRAIN, WITH […]
1 October 2021 · Injury · SIGNA PET/MR · GE MEDICAL SYSTEMS, LLC · report 2183553-2021-00010
IT WAS REPORTED THAT DURING INSTALLATION OF A PET/MR SYSTEM, TWO FIELD ENGINEERS (FE) WERE PLACING SHIM TRAYS INTO THE MR SYSTEM. WHILE THEY WERE IN THE PROCESS OF PUSHING A SHIM TRAY INWARD USING A SPECIALIZED GE HEALTHCARE SERVICE TOOL, ONE OF THE FE'S GLOVES HAD BECOME CAUGHT AND HIS FINGER PINCHED. THE PINCH RESULTED IN A LACERATION OF HIS LEFT INDEX FINGER WHICH REQUIRED SEVEN SUTURES.
19 October 2020 · Malfunction · INGENUITY TF PET/MR · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · report 3015777306-2020-00017
THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED WAS THAT PET/MR TABLE DID NOT STOP AT THE REQUESTED POSITION. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT.
14 November 2018 · Injury · SIGNA PET/MR · GE MEDICAL SYSTEMS, LLC · report 2183553-2018-00017
IT WAS REPORTED THAT A PATIENT UNDERWENT AN MRI OF THE INTERNAL AUDITORY CANALS (IACS) TO EVALUATE A PRE-EXISTING CONDITION OF LEFT SIDED VESTIBULAR SCHWANNOMA AND LEFT SIDE HEARING LOSS. THE PATIENT WAS PROVIDED APPROPRIATE EARPLUGS BY THE CUSTOMER FOR THE EXAM. THE PATIENT RETURNED TO THE RADIOLOGY DEPARTMENT AFTER THE MRI EXAM HAD BEEN COMPLETED TO REPORT HEARING LOSS IN THE RIGHT EAR. THE PATIENT WAS EVALUATED BY THE SITE'S AUDIOLOGY DEPARTMENT WHERE NEW HEARING LOSS IN THE RIGHT EAR WAS […]
27 April 2017 · Injury · SIGNA PET/MR · GE MEDICAL SYSTEMS, LLC · report 2183553-2017-00006
IT WAS INITIALLY REPORTED THAT A PATIENT, WHO WAS WEARING EAR PLUGS, COMPLAINED OF NOT BEING ABLE TO HEAR AFTER A MRI EXAM. THE PATIENT WAS SENT TO THE SITE'S NURSING STATION FOR CARE, HOWEVER NO DETAILS WERE PROVIDED THAT THE PATIENT REQUIRED OR RECEIVED MEDICAL TREATMENT. THE SITE FOLLOWED UP THE FOLLOWING DAY AND THE PATIENT SAID THAT IT HAD IMPROVED BUT NOT FULLY. THE CUSTOMER LATER CONFIRMED THAT THE PATIENT HAD MILD SENSORINEURAL HEARING LOSS AT 2 KHZ IN THE RIGHT EAR. BASELINE HEARING […]
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 OUO, in Radiology, from Siemens Healthineers AG, or cleared in 2026. 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.