Identity
- Trade Name
- ScanX Duo Touch FDA UDI
- Generic Name
- Dental computed radiography digital imaging scanner FDA UDI
- Device Name
- ScanX Duo Touch EUDAMEDThe ScanX is intended to be used for scanning and processing digital images exposed on photostimulable phosphor storage plates in dental applications. FDA UDI
- Model / Reference
- J1200 EUDAMEDJ1205 FDA UDI
- Description
- The ScanX is intended to be used for scanning and processing digital images exposed on photostimulable phosphor storage plates in dental applications. FDA UDI
Identifiers
- Catalog Number
- J1200 FDA UDI
- Primary DI / UDI-DI
- +D678J12050 EUDAMEDD678J12050 FDA UDI
- Basic UDI-DI
- ++D678J1200T6 EUDAMED
- 510(k) Number
- K191623 FDA UDI
- FDA Product Code
- MUH FDA UDI
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Dental computed radiography digital imaging scanner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Dental computed radiography digital imaging scanner
ScanX Duo Touch by Air Techniques, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental computed radiography digital imaging scanner.
- ACTEON — SOPRO · Class II
- Nical Smart Micro — NICAL SPA · Class II
- CS 7400 — CARESTREAM HEALTH, INC. · Class II
- ACTEON — SOPRO · Class II
- ScanX Classic View — DÜRR DENTAL SE · Class II
- RIOScan — Ray Co., Ltd · Class II
- ScanX Swift View 2.0 — DÜRR DENTAL SE · Class II
- CS 7600 — CARESTREAM HEALTH, INC. · Class II
Cleared under the same submission
K191623 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Air Techniques, Inc.
Sources (2)
- FDA UDI 7f19d349-e801-40a0-866e-1c2f323a4fbb 36 fields · synced Jul 8, 2026
- EUDAMED 23c6c62b-72a5-43b0-b5be-1523a4d2aa86 61 fields · synced Jul 8, 2026