FireCR Dental

FDA UDI

Class II (US FDA UDI)

by DIGIRAY Corp.

Identity

Trade Name: FireCR Dental FDA UDI
Generic Name: Computed radiography digital imaging scanner FDA UDI
Device Name: The advanced CR technology of the FireCR Dental Reader enables you to produce high-quality digital images for diagnosing the patients in your facility. The reader can be used as a central reader, which distributes images throughout your facility, or as an exam-room based solution. The reader is DICOM 3.0 compatible with existing systems and uses a full range of low-cost, reusable bitewings and intraoral imaging plates. The design features a built-in erase function and a color touch-screen LCD panel without physical push buttons for seamless device operation. FDA UDI
Model / Reference: FR11 FDA UDI
Description: The advanced CR technology of the FireCR Dental Reader enables you to produce high-quality digital images for diagnosing the patients in your facility. The reader can be used as a central reader, which distributes images throughout your facility, or as an exam-room based solution. The reader is DICOM 3.0 compatible with existing systems and uses a full range of low-cost, reusable bitewings and intraoral imaging plates. The design features a built-in erase function and a color touch-screen LCD panel without physical push buttons for seamless device operation. FDA UDI

Identifiers

Catalog Number: CG-702 FDA UDI
Primary DI / UDI-DI: 08809466040214 FDA UDI
510(k) Number: K131442 FDA UDI
FDA Product Code: MUH FDA UDI
GMDN Term: Computed radiography digital imaging scanner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.1800 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

Yes

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Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

Yes

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Dimensions & Sizes

Size: Weight — 4.7 Kilogram FDA UDI
Width — 12.0 Centimeter FDA UDI
Length — 31.8 Centimeter FDA UDI
Height — 26.5 Centimeter FDA UDI

Category: Computed radiography digital imaging scanner

FireCR Dental by DIGIRAY Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Computed radiography digital imaging scanner.

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FUJI IMAGING PLATE — FUJIFILM Corporation · Class I
CR-IR 392 — FUJIFILM Corporation · Class II
CANON INC. — CANON INC. · Class II
Radlink CR Pro 2200 — RADLINK, INC. · Class II

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: DIGIRAY Corp.

Sources (1)

FDA UDI 466db956-9311-4494-9654-ea80ed0b7bf6 37 fields · synced May 30, 2026