SNC125c Scanning Ionization Chamber (TNC)

FDA UDI

Class II (US FDA UDI)

by Sun Nuclear Corporation

Identity

Trade Name: SNC125c Scanning Ionization Chamber (TNC) FDA UDI
Generic Name: Solid-state-semiconductor radiation measuring probe FDA UDI
Device Name: Radiation therapy QA device. FDA UDI
Model / Reference: 10410001Z FDA UDI
Description: Radiation therapy QA device. FDA UDI

Identifiers

Catalog Number: 10410001Z FDA UDI
Primary DI / UDI-DI: B01610410001Z0 FDA UDI
510(k) Number: K112981 FDA UDI
FDA Product Code: LHN FDA UDI
GMDN Term: Solid-state-semiconductor radiation measuring probe FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5050 FDA UDI
Commercial Distribution: Not 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

SNC125c Scanning Ionization Chamber (TNC) by Sun Nuclear Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K112981 also covers:

Manufacturer's product page: SNC125c, SNC350p, SNC600c Proven Reference Ion Chambers

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: Sun Nuclear Corporation

Sources (1)

FDA UDI 17ad81a2-cfba-4e04-84ee-cb6415a8c9a5 37 fields · synced Jun 8, 2026