FireCR Flash

FDA UDI

Class II (US FDA UDI)

by DIGIRAY Corp.

Identity

Trade Name: FireCR Flash FDA UDI
Generic Name: Computed radiography digital imaging scanner FDA UDI
Device Name: The FireCR Flash can be configured for nearly every clinical application, and is designed for full DICOM connectivity, and allows user to setup the system to capture high quality X-ray images of any body parts with minimal steps including reading, processing, displaying and sending of the high quality image. All imaging parameters are optimized, resulting in digital images that can be enhanced, enlarged, duplicated, and sent to any location as a DICOM 3.0 file format in seconds with no loss of resolution. FDA UDI
Model / Reference: FR41 FDA UDI
Description: The FireCR Flash can be configured for nearly every clinical application, and is designed for full DICOM connectivity, and allows user to setup the system to capture high quality X-ray images of any body parts with minimal steps including reading, processing, displaying and sending of the high quality image. All imaging parameters are optimized, resulting in digital images that can be enhanced, enlarged, duplicated, and sent to any location as a DICOM 3.0 file format in seconds with no loss of resolution. FDA UDI

Identifiers

Catalog Number: CG-401 FDA UDI
Primary DI / UDI-DI: 08809466040412 FDA UDI
510(k) Number: K133120 FDA UDI
FDA Product Code: MQB FDA UDI
GMDN Term: Computed radiography digital imaging scanner 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Weight — 21.5 Kilogram FDA UDI
Width — 44.4 Centimeter FDA UDI
Length — 79.5 Centimeter FDA UDI
Height — 13.4 Centimeter FDA UDI

Category: Computed radiography digital imaging scanner

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

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Cleared under the same submission

K133120 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 II	Pending data

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Manufacturer

Manufacturer: DIGIRAY Corp.

Sources (1)

FDA UDI 7e5e5839-f84a-4fb7-b0ec-cda36e7774f8 37 fields · synced May 30, 2026