Luminscan(TM) Disposable Imaging Kit

FDA UDI

Class II (US FDA UDI)

by Micro-Tech (Nanjing) Co., Ltd.

Identity

Trade Name: Luminscan(TM) Disposable Imaging Kit FDA UDI
Generic Name: Coronary optical coherence tomography system FDA UDI
Device Name: The diameter of the balloon is 16mm, the effective length is 80mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm FDA UDI
Model / Reference: BOP-16-80-25-7 FDA UDI
Description: The diameter of the balloon is 16mm, the effective length is 80mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm FDA UDI

Identifiers

Primary DI / UDI-DI: 06932503570046 FDA UDI
510(k) Number: K162466 FDA UDI
FDA Product Code: NQQ FDA UDI
GMDN Term: Coronary optical coherence tomography system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Balloon Diameter — 16 Millimeter FDA UDI
Balloon Length — 80 Millimeter FDA UDI
Length — 250 Centimeter FDA UDI

Category: Coronary optical coherence tomography system

Luminscan(TM) Disposable Imaging Kit by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K162466 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Micro-Tech (Nanjing) Co., Ltd.

Sources (1)

FDA UDI 7e3307b9-7af6-428c-b9ab-c46842347352 36 fields · synced May 31, 2026