FDA.reportPublic FDA data

AptiVue™

Primary DI
05415067048882
Brand
AptiVue™
Company
LIGHTLAB IMAGING, INC.
Model
1015209
Catalog number
1015209
Device description
Imaging Software Upgrade Kit
Published
2023-09-29
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
NQQSYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQQSystem, Imaging, Optical Coherence Tomography (Oct)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232386000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232386000ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6ABBOTT MEDICAL2023-09-08NQQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067048882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067048882054150670488825415067048882

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
018493531
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067054920Ultreon™ULTR300001ULTR3000012026-05-19
05415067053879ILUMIEN™ OPTIS™ to OPTIS™UIMG901003UIMG9010032025-07-31
05415067047694Ultreon™101531010153102024-03-29
05415067025715PressureWire™C12059C120592016-08-19
05415067025739PressureWire™C12009C120092016-08-19
05415067025722PressureWire™C12359C123592016-08-19
00183739000647Dragonfly™ OPTIS™C408645C4086452015-04-20
00183739000654Dragonfly™ OPTIS™C408646C4086462015-04-20
05415067037626Ultiri™101508210150822022-08-12
05415067031129Dragonfly OpStar™101465110146512019-12-17
00183739000678ILUMIEN™C408650C4086502016-03-23
00812059020126OPTIS™C408653C4086532015-09-28
05415067030856AptiVue™101466610146662020-10-26
00183739000937OPTIS™Integrated SystemC4086522015-09-28
00812059021420OPTIS™Mobile SystemC4086612015-12-21
00183739000562C7 Dragonfly™100-100-00100-100-002015-04-17
00183739000623Dragonfly™Kit100-100-KT2015-04-20
00183739000630ILUMIEN™900-700-00900-700-002016-03-23
00183739000692Dragonfly™Duo KitC4086432015-04-20
00183739000708Dragonfly™DuoC4086442015-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874783659LIA ConsoleLEADOPTIK INC.NQQ2026-06-01
05415067054920Ultreon™LIGHTLAB IMAGING, INC.NQQ2026-05-19
00812763011007OPUSWAVETerumo Cardiovascular Systems CorporationNQQ2026-05-13
06975417183858PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06975417183865PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06975417183872PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06975417183889PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06971141530494Cornaris Intravascular Imaging SystemShenzhen Vivolight Medical Device & Technology Co., Ltd.NQQ2025-09-28
06971141530500Cornaris Intravascular Imaging SystemShenzhen Vivolight Medical Device & Technology Co., Ltd.NQQ2025-09-28
03775000102715deepLiveDAMAE MEDICALNQQ2025-09-24
05415067053879ILUMIEN™ OPTIS™ to OPTIS™LIGHTLAB IMAGING, INC.NQQ2025-07-31
05415067047694Ultreon™LIGHTLAB IMAGING, INC.NQQ2024-03-29
00860008045508Starlight Imaging CatheterSpectrawave, Inc.NQQ2024-02-23
00860008045515HyperVue Imaging SystemSpectrawave, Inc.NQQ2024-02-23
00851354004509Lightbox L3AVINGER, INC.NQQ2024-01-29
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06932503570091Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570107Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570029MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570036MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570043MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570050MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570067MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570074MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11