← Back to catalogue

LuminScan(TM) Imaging System

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
LuminScan(TM) Imaging System FDA UDI
Generic Name
Coronary optical coherence tomography system FDA UDI
Device Name
The machine model is C1, the light source sweep frequency is 100kHz FDA UDI
Model / Reference
EOCT-C1-10-10 FDA UDI
Description
The machine model is C1, the light source sweep frequency is 100kHz FDA UDI

Identifiers

Primary DI / UDI-DI
26932503570019 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coronary optical coherence tomography system

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

Similar devices

Also classified as Coronary optical coherence tomography system.

Cleared under the same submission

K162466 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (1)

  • FDA UDI 1f10b551-ea2e-4f52-85e5-3552ab41fdc2 35 fields · synced Jun 7, 2026