FDA.reportPublic FDA data

Novasight Hybrid™ Hummingbird Console

Primary DI
00628055603078
Brand
Novasight Hybrid™ Hummingbird Console
Company
Conavi Medical Inc
Model
TA-03-0005
Device description
Imaging System
Published
2020-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
NQQSystem, Imaging, Optical Coherence Tomography (Oct)
OBJCatheter, Ultrasound, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
NQQSystem, Imaging, Optical Coherence Tomography (Oct)Radiology2
OBJCatheter, Ultrasound, IntravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172258000Novasight Hybrid SystemConavi Medical, Inc.2018-04-27OBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628055603078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628055603078006280556030786280556030780628055603078

GMDN Terms#

Term, Definition table
TermDefinition
Coronary optical coherence tomography systemAn assembly of optical and computer-based devices that use a broad-bandwidth light beam for optical coherence tomography (OCT) to provide high-resolution images (e.g., 5 to 40 microns) of the coronary intravasculature. It typically consists of a main operator's console which includes a computer for image storage, keyboard/mouse controls, and a visual display unit (VDU); audio recording facilities; and a printer. The system includes an optical-imaging catheter which is connected to the console for transmission of the images from the intravascular site. The system may be used during interventional cardiology, radiology, or diagnostic angiography.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
416-483-0100customerservice@conavi.com

Regulatory Flags#

DUNS number
200125243
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628055603115Novasight Hybrid™ CatheterTA-06-00012023-04-17
00628055603054Novasight Hybrid™ CatheterTA-06-00012020-09-09
00628055603092Novasight Hybrid™ PIMTA-07-00022022-10-25
00628055603016Foresight ICE™ CatheterTA-01-00012020-09-11
01628055603015Foresight ICE™ CatheterTA-01-00012020-09-11
00628055603023Foresight ICE™ Catheter Accessories PackageSA-01-00152020-09-11
00628055603030Foresight ICE™ Hummingbird ConsoleTA-03-00012020-09-11
00628055603047Foresight ICE™ PIMTA-02-00012020-09-11
00628055603061Novasight Hybrid™ Catheter Accessories PackageSA-10-00222020-09-11
00628055603085Novasight Hybrid™ PIMTA-07-00012020-09-11
00628055603108Novasight Hybrid™ Catheter PIM BagSA-10-00292020-09-11
01628055603053Novasight Hybrid™ CatheterTA-06-00012020-09-09

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00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYO2026-06-24
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