FDA.reportPublic FDA data

NOVA

Primary DI
00867170000106
Brand
NOVA
Company
VASSOL, INC.
Model
VS5060
Device description
Vascular Flow Analysis System
Published
2016-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K014011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014011000CANVAS N-VAS-D 2.0Vassol, Inc.2002-02-05LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867170000106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867170000106008671700001068671700001060867170000106

GMDN Terms#

Term, Definition table
TermDefinition
MRI system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a magnetic resonance imaging (MRI) system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
708-366-7000support@vassolinc.com

Regulatory Flags#

DUNS number
089134433
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573596200865APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200889APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200896APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200902APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200940APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200964APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200971APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596201480APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596201497APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596201503APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596202210APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596202227APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
07090042053051BatteryBoxNordicneurolab ASLNH2026-04-01
07090042053068HeadSet 3TNordicneurolab ASLNH2026-04-01
07090042053075BatteryChargerNordicneurolab ASLNH2026-04-01
07090042053082AccessPointNordicneurolab ASLNH2026-04-01
07090042053099AudioHubNordicneurolab ASLNH2026-04-01
00857534006929Neuro II-SEIMRIS Imaging, Inc.LNH2026-03-20
B66910103G TransducerMRIAUDIO, INC.LNH2026-03-06
B6693300MRIaudio Over-Ear HeadphonesMRIAUDIO, INC.LNH2026-03-06
B66915070MRIaudioMRIAUDIO, INC.LNH2026-03-03
04068151995268MAGNETOM LuminaSiemens Healthineers AGLNH2026-02-23
04068151995312MAGNETOM Sola FitSiemens Healthineers AGLNH2026-02-23
00884838104402IngeniaPhilips Medical Systems Nederland B.V.LNH2026-01-27
04056869299594MAGNETOM Flow.NeoSiemens Healthcare GmbHLNH2026-01-19
04068151034196MAGNETOM Flow.EliteSiemens Healthcare GmbHLNH2026-01-19
00884838128415Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128422Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128439Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128446Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07