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Sedecal

FDA UDI

Class II (US FDA UDI)

by Sedecal., Sa.

Identity

Trade Name
SEDECAL FDA UDI
Generic Name
Portable basic diagnostic x-ray system, analogue FDA UDI
Device Name
This Portable Diagnostic Radiographic System is 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
SPL-HF-2.0 FDA UDI
Description
This Portable Diagnostic Radiographic System is 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

Primary DI / UDI-DI
08436046001770 FDA UDI
510(k) Number
K103522 FDA UDI
FDA Product Code
IZL FDA UDI
GMDN Term
Portable basic diagnostic x-ray system, analogue FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1720 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

Yes

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

Category: Portable basic diagnostic x-ray system, analogue

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

Similar devices

Also classified as Portable basic diagnostic x-ray system, analogue.

Cleared under the same submission

K103522 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sedecal., Sa.

Sources (1)

  • FDA UDI 00dbfb28-a2c1-4429-8302-2358ba6a1062 35 fields · synced May 30, 2026