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SPECTO MEDICAL AG

Matched from indexed company URL: Specto Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30381363203038136320SPECTO MEDICAL AG1N2026-01-01Elisabethenstrasse 18 Basel Basel-Stadt CH 4051

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3381551580071158K242205SpectoMed (v1.0)LLZ2025-01-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ12025-01-14

PMN#

GUDID#

SpectoMED - SpectoMed provides real-time spatial-visualization of medical imaging allowing the manipulation, processing, review, analysis, communication and media interchange of multi-dimensional digital images of several modalities as defined by the DICOM standard, such as CT or MRI imaging datasets. Furthermore, SpectoMed aids the clinician in the preparation of a surgical intervention with measurements and import of compatible objects within the realistic spatial visuals of the patient’s anatomy as well as their intraoperative display. SpectoMed is intended as an aid for assessing patient images.

Specto Medical AG

2025-03-31