Sedecal

FDA UDI

Class II (US FDA UDI)

by Sedecal., Sa.

Identity

Trade Name: SEDECAL FDA UDI
Generic Name: Mobile basic diagnostic x-ray system, digital FDA UDI
Device Name: Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography FDA UDI
Model / Reference: AeroDR TX m01 FDA UDI
Description: Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography FDA UDI

Identifiers

Catalog Number: 3640 FDA UDI
Primary DI / UDI-DI: 08436046003125 FDA UDI
510(k) Number: K221803 FDA UDI
FDA Product Code: MQB FDA UDI
IZL FDA UDI
GMDN Term: Mobile basic diagnostic x-ray system, digital FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1680 FDA UDI
892.1720 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

Yes

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: Mobile basic diagnostic x-ray system, digital

Sedecal by Sedecal., Sa. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Micro-X — Micro-X , Ltd. · Class II

Cleared under the same submission

K221803 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: Sedecal., Sa.

Sources (1)

FDA UDI 3c4a9adf-8144-4d20-b4ee-99643f9bbc3d 36 fields · synced May 30, 2026