Identity
- Trade Name
- Imagescan HD FDA UDI
- Generic Name
- Stationary intraoral dental x-ray system, digital FDA UDI
- Device Name
- Imagescan HD with 33" Straight arm is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in Dental Radiography for diagnostic purpose FDA UDI
- Model / Reference
- 303-001203-0 FDA UDI
- Description
- Imagescan HD with 33" Straight arm is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in Dental Radiography for diagnostic purpose FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08904269400583 FDA UDI
- 510(k) Number
- K170967 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- Stationary intraoral dental x-ray system, digital 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
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
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: Stationary intraoral dental x-ray system, digital
Imagescan HD by Skanray Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary intraoral dental x-ray system, digital.
- Midmark PREVA IntraOral Dental X-ray System — Midmark Corporation · Class II
- Midmark PREVA IntraOral Dental X-ray System — Midmark Corporation · Class II
- X-MIND unity — DE GÖTZEN SRL · Class II
- Stern Weber — CEFLA SOCIETA' COOPERATIVA · Class II
- Midmark PREVA 2.0 IntraOral Dental X-ray System — Midmark Corporation · Class II
- PREVA, 66" REACH EXPORT W/TWO STUD MOUNT — Midmark Corporation · Class II
- Midmark — Midmark Corporation · Class II
- Owandy-RX DC — OWANDY RADIOLOGY · Class II
Cleared under the same submission
K170967 also covers:
- Imagescan HD — Skanray Technologies
- Imagescan HD — Skanray Technologies
- Imagescan HD — Skanray Technologies
- Intraskan DC Plus — Skanray Technologies
- Intraskan DC Plus — Skanray Technologies
- Intraskan DC Plus — Skanray Technologies
- Intraskan DC Plus — Skanray Technologies
- Rayos DC — Skanray Technologies
- Rayos DC — Skanray Technologies
- Rayos DC — Skanray Technologies
- Rayos DC — Skanray Technologies
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
- Skanray Technologies
Sources (1)
- FDA UDI b7f8da19-2e86-4a11-be44-0037e37c37eb 35 fields · synced Jun 8, 2026