Exprimer

FDA UDI

Class II (US FDA UDI)

by Drtech Corp.

Identity

Trade Name: Exprimer FDA UDI
Generic Name: Indirect flat panel x-ray detector FDA UDI
Device Name: The EVS 3643G Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light. FDA UDI
Model / Reference: EVS 3643G FDA UDI
Description: The EVS 3643G Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800018402702 FDA UDI
510(k) Number: K162552 FDA UDI
FDA Product Code: MQB FDA UDI
GMDN Term: Indirect flat panel x-ray detector FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1680 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

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: Indirect flat panel x-ray detector

Exprimer by Drtech Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Indirect flat panel x-ray detector.

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P-53 — Konica Minolta, Inc. · Class II
LG — Lg Electronics · Class II
DRX-1 Detector — CARESTREAM HEALTH, INC. · Class II
P-75 — Konica Minolta, Inc. · Class II
PEDRA — Radisen Co., Ltd. · Class II

Cleared under the same submission

K162552 also covers:

Exprimer — Drtech Corp.

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: Drtech Corp.

Sources (1)

FDA UDI 890dfbb5-bb70-4862-9ec2-80c89159539b 34 fields · synced May 30, 2026