Radiology · 510(k) · 2023
MAGNETOM Free.Max; MAGNETOM Free.Star
Siemens Medical Solutions USA, Inc.. Cleared by FDA on 9 November 2023 under submission K231617, product code LNH (system, nuclear magnetic resonance imaging). What FDA's record says, in FDA's words.
Device record · K231617
- Device. MAGNETOM Free.Max; MAGNETOM Free.StarDEVICE
- Company. Siemens Medical Solutions USA, Inc.COMPANY
- Decision. 9 November 2023, 510(k), substantially equivalent (traditional review); received 2 June 2023DECISION
- Panel. RadiologyPANEL
- Product code. LNH, System, Nuclear Magnetic Resonance ImagingCODE
- Regulation. 21 CFR 892.1000, Class IIREG
- Source. FDA database entry · decision document (13 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.
for the subject device MAGNETOM Free.Max with syngo MR XA60A is extended to include MR imaging during interventional procedures compared to the predicate device MAGNETOM Free.Max with syngo MR XA50A: MAGNETOM Free.Max system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal, and oblique cross-sectional images that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images may also be produced. Depending on the region of interest, contrast agents may be used. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist in diagnosis. MAGNETOM Free.Max may also be used for imaging during interventional procedures when performed with MR-compatible devices such as MR Safe biopsy needles. MAGNETOM Free.Star: The indications for use for the subject device MAGNETOM Free.Star with syngo MR XA60A is the same as the predicate device MAGNETOM Free.Star with syngo MR XA50A: MAGNETOM Free.Star system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal, and oblique cross-sectional images that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images may also be produced. Depending on the region of interest, contrast agents may be used. These […]
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
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 4,787 reports filed against devices carrying product code LNH. 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 · Achieva 1.5T Dstream · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000174
28 September 2026 · Malfunction · Achieva 1.5T · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000166
Philips received a report that the Quadrature Body Coil (QBC) seal on the front cover is coming loose. This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal is loose, it is likely that this could lead to serious injury.
28 September 2026 · Malfunction · Ingenia · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000167
Philips received a report that the upper Quadrature Body Coil (QBC) seal has peeling off. This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal is peeled it is likely that this could lead to serious injury.
28 September 2026 · Malfunction · Ingenia · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000168
Philips received a report that the Quadrature Body Coil (QBC) seal has come loose. This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal comes loose it is likely that this could lead to serious injury.
28 September 2026 · Malfunction · Ingenia · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000169
Philips received a report that the upper Quadrature Body Coil (QBC) seal has come loose This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal is loose it is likely that this could lead to serious injury.
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 LNH, in Radiology, from Siemens Medical Solutions USA, Inc., or cleared in 2023. 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.