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Fluobeam Lx

FDA UDI

Class II (US FDA UDI)

by Fluoptics

Identity

Trade Name
FLUOBEAM LX FDA UDI
Generic Name
Diagnostic-imaging multiformat camera FDA UDI
Device Name
Fluorescence imaging system FDA UDI
Model / Reference
FBLX FDA UDI
Description
Fluorescence imaging system FDA UDI

Identifiers

Primary DI / UDI-DI
B475FBLX0 FDA UDI
510(k) Number
K190891 FDA UDI
FDA Product Code
QDG FDA UDI
GMDN Term
Diagnostic-imaging multiformat camera FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic-imaging multiformat cameraIntraoperative parathyroid detection system control unit

Fluobeam Lx by Fluoptics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraoperative parathyroid detection system control unit.

Cleared under the same submission

K190891 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fluoptics

Sources (1)

  • FDA UDI 3f34ea4a-36b6-4ab6-9ed4-b10cabf38265 34 fields · synced May 30, 2026