Infrared imaging unit

FDA UDI

Class I (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name: Infrared imaging unit FDA UDI
Generic Name: Software upgrade/unlocking key FDA UDI
Model / Reference: MAJ-2304 FDA UDI

Identifiers

Primary DI / UDI-DI: 04953170395994 FDA UDI
510(k) Number: K190772 FDA UDI
FDA Product Code: EPT FDA UDI
IZI FDA UDI
GMDN Term: Software upgrade/unlocking key FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4700 FDA UDI
892.1600 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Software upgrade/unlocking key

Infrared imaging unit by Olympus Medical Systems Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K190772 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 I	Pending data

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Manufacturer

Manufacturer: Olympus Medical Systems Corporation

Sources (1)

FDA UDI cec705b7-3c7e-4c9b-824e-6eb073dc9720 34 fields · synced May 31, 2026