Identity
- Trade Name
- INTRASKAN DC FDA UDI
- Generic Name
- Diagnostic x-ray system generator, mobile FDA UDI
- Device Name
- INTRASKAN DC FLOOR MOUNT FDA UDI
- Model / Reference
- 9992720300 FDA UDI
- Description
- INTRASKAN DC FLOOR MOUNT FDA UDI
Identifiers
- Catalog Number
- 9992720300 FDA UDI
- Primary DI / UDI-DI
- D83399927203000 FDA UDI
- 510(k) Number
- K103579 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- Diagnostic x-ray system generator, mobile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 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
No
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, mobile
Intraskan Dc by ImageWorks — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Diagnostic x-ray system generator, mobile.
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- Anthem Generator — DEL MEDICAL, INC. · Class I
- Anthem Generator — DEL MEDICAL, INC. · Class I
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- SR-1260-G — Source-Ray, Inc. · Class II
Cleared under the same submission
K103579 also covers:
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
- ImageWorks
Sources (1)
- FDA UDI f72b2712-f4fa-490c-9a1e-69ce13b269df 35 fields · synced Jun 8, 2026