Qg-32-Se

FDA UDI

Class I (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name: QG-32-SE FDA UDI
Generic Name: Diagnostic x-ray system generator, stationary FDA UDI
Device Name: QG-3200-4 ODYSSEY SE GEN 32KW FDA UDI
Model / Reference: QG-32-SE FDA UDI
Description: QG-3200-4 ODYSSEY SE GEN 32KW FDA UDI

Identifiers

Catalog Number: 1015239 FDA UDI
Primary DI / UDI-DI: 60889974000962 FDA UDI
FDA Product Code: IZO FDA UDI
GMDN Term: Diagnostic x-ray system generator, stationary FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.1700 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Diagnostic x-ray system generator, stationary

Qg-32-Se by Carestream Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic x-ray system generator, stationary.

EDITOR HFe 601 — Spellman High Voltage Electronics GmbH · Class IIb
SEDECAL — Sedecal., Sa. · Class I
SEDECAL — Sedecal., Sa. · Class I
EDITOR HFe 601 — Spellman High Voltage Electronics GmbH · Class IIb
SEDECAL — Sedecal., Sa. · Class I
S Spellman High Voltage Electronics Corporation — Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd · Class I
EDITOR HFe 601 — Spellman High Voltage Electronics GmbH · Class IIb
iRay — Iray Imaging Technology (Haining) Limited · Class I

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Carestream Health, Inc.

Sources (1)

FDA UDI ddc3d8fe-ffa4-4388-8c4f-4c328eaf8570 34 fields · synced Jun 8, 2026