Identity
- Trade Name
- ANCORIS FDA UDI
- Generic Name
- PET system FDA UDI
- Device Name
- The ‘ANCORIS’ PET Scanner is designed to acquire data, process and display images by appropriated trained medical professionals via measuring the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body. FDA UDI
- Model / Reference
- ANCORIS FDA UDI
- Description
- The ‘ANCORIS’ PET Scanner is designed to acquire data, process and display images by appropriated trained medical professionals via measuring the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260484140067 FDA UDI
- 510(k) Number
- K201807 FDA UDI
- FDA Product Code
- KPS FDA UDI
- GMDN Term
- PET system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1200 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: PET system
Ancoris by MiE medical imaging electronics GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- MiE medical imaging electronics GmbH
Sources (1)
- FDA UDI 2f4fde6e-5382-4aed-8aeb-199dc2fd306f 34 fields · synced May 30, 2026