FDA.reportPublic FDA data

OPUSWAVE

Primary DI
00812763011007
Brand
OPUSWAVE
Company
Terumo Cardiovascular Systems Corporation
Model
01000-00
Device description
Dual Sensor Imaging System
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K250684000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250684000OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi Plant2025-07-02NQQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812763011007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812763011007008127630110078127630110070812763011007

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
177655466
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00699753537880Cardiovascular Procedure Kit788312026-08-26
00699753537897Cardiovascular Procedure Kit788332026-08-26
00699753537903Cardiovascular Procedure KitCX-CZ226X2026-08-26
00699753537910Cardiovascular Procedure KitCX-UK7672026-08-26
00699753537927Cardiovascular Procedure KitCX-UK7682026-08-26
00699753537934Cardiovascular Procedure KitCX-UK7692026-08-26
00699753537941Cardiovascular Procedure KitCX-UK770X2026-08-26
00699753537958Cardiovascular Procedure KitCX-UK7712026-08-26
00699753537866Cardiovascular Procedure Kit75643-052026-08-21
00699753537873Cardiovascular Procedure Kit787982026-08-21
00699753537811Cardiovascular Procedure KitCX-PL1642026-08-17
00699753537828Cardiovascular Procedure KitCX-PL1652026-08-17
00699753537743Cardiovascular Procedure Kit788052026-08-03
00699753537750Cardiovascular Procedure Kit788122026-08-03
00699753537767Cardiovascular Procedure Kit786712026-08-03
00699753530638Cardiovascular Procedure Kit75972-022024-02-22
00699753532625Cardiovascular Procedure Kit783422024-08-09
00699753532311Cardiovascular Procedure Kit74737-022024-07-22
00699753532083Cardiovascular Procedure Kit77746-012024-07-09
00699753531734Cardiovascular Procedure Kit76373-022024-06-12

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
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
05415067048882AptiVue™LIGHTLAB IMAGING, INC.NQQ2023-09-29
06932503570022Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570039Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570046Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570053Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570060Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570077Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570084Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
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