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Scintron

FDA UDI

Class II (US FDA UDI)

by MiE medical imaging electronics GmbH

Identity

Trade Name
SCINTRON FDA UDI
Generic Name
Nuclear medicine system operator console, multi-purpose FDA UDI
Device Name
Gamma Camera Workstation for Acquisition, Reviewing and Processing FDA UDI
Model / Reference
SCINTRON FDA UDI
Description
Gamma Camera Workstation for Acquisition, Reviewing and Processing FDA UDI

Identifiers

Primary DI / UDI-DI
04260484140050 FDA UDI
510(k) Number
K101013 FDA UDI
FDA Product Code
KPS FDA UDI
GMDN Term
Nuclear medicine system operator console, multi-purpose FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1200 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: Nuclear medicine system operator console, multi-purpose

Scintron by MiE medical imaging electronics GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nuclear medicine system operator console, multi-purpose.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MiE medical imaging electronics GmbH

Sources (1)

  • FDA UDI 1c7632fe-c1e0-46c2-8ccf-431d2b6df073 35 fields · synced May 30, 2026