Identity
- Trade Name
- IMAGE DIAGNOSTICS INC FDA UDI
- Generic Name
- Basic diagnostic x-ray system table, powered FDA UDI
- Device Name
- IDI,TABLE,VERT.-HORIZ. TABLETOP MOVEMENT,VASCULAR-INTERVENTIONAL-IMAGING,ASPECT 100-4,120V-230V, 24in x 84in TABLETOP WITH FULL LENGTH RAILS,NORTH AMERICA ACC'Y RAILS,#A100-3892 FDA UDI
- Model / Reference
- 100-4 FDA UDI
- Description
- IDI,TABLE,VERT.-HORIZ. TABLETOP MOVEMENT,VASCULAR-INTERVENTIONAL-IMAGING,ASPECT 100-4,120V-230V, 24in x 84in TABLETOP WITH FULL LENGTH RAILS,NORTH AMERICA ACC'Y RAILS,#A100-3892 FDA UDI
Identifiers
- Catalog Number
- A100-3892 FDA UDI
- Primary DI / UDI-DI
- 00850061871015 FDA UDI
- FDA Product Code
- IXR FDA UDI
- GMDN Term
- Basic diagnostic x-ray system table, powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1980 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
No
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: Basic diagnostic x-ray system table, powered
Image Diagnostics Inc by Image Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic diagnostic x-ray system table, powered.
- SEDECAL — Sedecal., Sa. · Class II
- Headboard Assembly — IMRIS Imaging, Inc. · Class II
- DRGEM — DRGEM Corporation · Class II
- APELEM — APELEM · Class II
- Del Medical/Universal — DEL MEDICAL, INC. · Class II
- BK-120MK — Shimadzu Corp. · Class II
- AeroDR T50 — Konica Minolta, Inc. · Class II
- APELEM — APELEM · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Image Diagnostics, Inc.
Sources (1)
- FDA UDI 0b2c4883-a523-4b6b-8790-5eb4bdcaca09 35 fields · synced May 30, 2026