FDA.reportPublic FDA data

MOBIUS IMAGING, LLC

Matched from indexed company URL: Mobius Imaging, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30101513773010151377MOBIUS IMAGING, LLC1N2026-01-012 Shaker Road Suite F100 Shirley MA US 01464

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
00869346000200Airo® - AIRO® Computed Tomography (CT) X-ray System978.796.5068nlemay@mobiusimaging.com
00869346000200Airo® - AIRO® Computed Tomography (CT) X-ray System800.253.3210INST.STRYKER.CS@STRYKER.COM

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2349351613308237K180393AIRO Computed Tomography (CT) X-ray SystemJAK2018-03-15
2349351760788256K160126AIRO Computed Tomography (CT) X-ray SystemJAK2016-04-19
2349351781677351K131431AIRO CT SYSTEMJAK2013-09-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAK32018-03-15

PMN#

GUDID#