Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008152219

FEI Number

3008152219

Entity Name

SPELLMAN HIGH VOLTAGE ELECTRONICS(SUZHOU INDUSTRIAL PARK)CO.,LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No.86 Jinjiang Road, Suzhou Industrial Park, 215127, P.R. China, Suzhou Jiangsu 215127, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Spellman High Voltage Electronics(Suzhou Industrial Park)Co. (Owner Number: 10055979)

Owner / Operator Contact Address

No.86 Jinjiang Road, Suzhou Industrial Park, 215127, P.R. China, Suzhou, CN-JS 215127, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SPELLMAN Spellman

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2017-10-24
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2021-04-27

Official Correspondent

Sherry Zhang

US Agent Details

Shalom Cohen Business: Spellman High Voltage Electronics Cooperation Email: scohen@spellmanhv.com Phone: (631) 6303643

Related Public Records

Same Entity

Spellman High Voltage Electronics(Suzhou Industrial Park)Co.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K950291	Fischer Imaging Corp.	DIGITAL 625HF	1995-03-23

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3003768251	Philips Medical Systems DMC GmbH	HAMBURG, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008152219. Last updated year: 2026. Please use registration number 3008152219 when referencing this establishment in official correspondence.