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AcuitySDR

FDA UDI

Class II (US FDA UDI)

by Radmedix, LLC

Identity

Trade Name
AcuitySDR FDA UDI
Generic Name
Stationary basic diagnostic x-ray system, digital FDA UDI
Model / Reference
Plus FDA UDI

Identifiers

Primary DI / UDI-DI
00810035220010 FDA UDI
510(k) Number
K193360 FDA UDI
FDA Product Code
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

No

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
Sterilization Method
Liquid Chemical FDA UDI

Category: Stationary basic diagnostic x-ray system, digital

AcuitySDR by Radmedix, LLC — 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

K193360 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Radmedix, LLC

Sources (1)

  • FDA UDI ceaf1224-325d-4bfb-9b28-66568954a72b 33 fields · synced May 30, 2026