← Back to catalogue

RADspeed fit

FDA UDI

Class II (US FDA UDI)

by Shimadzu Corp.

Identity

Trade Name
RADspeed fit FDA UDI
Generic Name
Stationary basic diagnostic x-ray system, digital FDA UDI
Model / Reference
566-12700-22 FDA UDI

Identifiers

Primary DI / UDI-DI
04540217059980 FDA UDI
510(k) Number
K173517 FDA UDI
FDA Product Code
MQB FDA UDI
KPR FDA UDI
GMDN Term
Stationary basic diagnostic x-ray system, digital 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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: Stationary basic diagnostic x-ray system, digital

RADspeed fit by Shimadzu Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary basic diagnostic x-ray system, digital.

Cleared under the same submission

K173517 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shimadzu Corp.

Sources (1)

  • FDA UDI 765f805f-ac72-44b1-83ad-951cdb33f2d9 33 fields · synced May 29, 2026