Identity
- Trade Name
- EDITOR HFe FDA UDI
- Generic Name
- Diagnostic x-ray system generator, stationary FDA UDI
- Device Name
- EDITOR HFe501 0.96m US 3P, 480V FDA UDI
- Model / Reference
- 501 FDA UDI
- Description
- EDITOR HFe501 0.96m US 3P, 480V FDA UDI
Identifiers
- Catalog Number
- 091480105 FDA UDI
- Primary DI / UDI-DI
- ESPN091480105 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Diagnostic x-ray system generator, stationary
EDITOR HFe by Spellman High Voltage Electronics Corp. — 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
- QG-32-SE — CARESTREAM HEALTH, INC. · Class I
- SEDECAL — Sedecal., Sa. · Class I
- EDITOR HFe 601 — Spellman High Voltage Electronics GmbH · Class IIb
- QG-50-2 — CARESTREAM HEALTH, INC. · Class I
- SEDECAL — Sedecal., Sa. · Class I
- S Spellman High Voltage Electronics Corporation — Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd · 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
- Spellman High Voltage Electronics Corp.
Sources (1)
- FDA UDI 4fd74c29-2cb3-4847-aa0e-f154acfa2fb0 34 fields · synced May 30, 2026