Identity
- Trade Name
- MiE - Gamma Camera Systems FDA UDI
- Generic Name
- Stationary gamma camera system FDA UDI
- Device Name
- The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients. FDA UDI
- Model / Reference
- SYNGULA-SCINTRON FDA UDI
- Description
- The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260484140043 FDA UDI
- 510(k) Number
- K053086 FDA UDI
- FDA Product Code
- IYX FDA UDI
- GMDN Term
- Stationary gamma camera system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1100 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 gamma camera system
MiE - Gamma Camera Systems by MiE medical imaging electronics GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K053086 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 I | Pending data |
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Manufacturer
- Manufacturer
- MiE medical imaging electronics GmbH
Sources (1)
- FDA UDI f2d25c65-f719-4a93-a99b-ef94b5ded571 35 fields · synced May 30, 2026