FDA.reportPublic FDA data

SPECTRONIC MEDICAL AB

Matched from indexed company URL: Spectronic Medical AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30253099243025309924SPECTRONIC MEDICAL AB1N2026-01-01Karbingatan 36 Helsingborg Skane SE 25467

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07350097430017MRI Planner - MRI Planner is a stand alone software product intended to enable a completely MRI only workflow inradiotherapy planning. The MRI Planner software achieves this by analyzing a dedicated MRimage and generating a synthetic CT image that can replace the conventional CT in the treatmentplanning process. In addition, the software also performs automated contouring of risk organs incertain anatomies. In the current version of MRI Planner, synthetic CT generation is supported forthe brain, head-neck and pelvis anatomies, whereas automated risk organ contouring issupported for bladder, colon and femoral heads for prostate cancer patients only.+4642252000support@spectronic.se

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3114621224440089K211841MRI PlannerMUJ2022-08-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MUJ12022-08-25

PMN#

GUDID#

MRI Planner - MRI Planner is a stand alone software product intended to enable a completely MRI only workflow inradiotherapy planning. The MRI Planner software achieves this by analyzing a dedicated MRimage and generating a synthetic CT image that can replace the conventional CT in the treatmentplanning process. In addition, the software also performs automated contouring of risk organs incertain anatomies. In the current version of MRI Planner, synthetic CT generation is supported forthe brain, head-neck and pelvis anatomies, whereas automated risk organ contouring issupported for bladder, colon and femoral heads for prostate cancer patients only.

Spectronic Medical AB

2023-01-31