Identity
- Trade Name
- D-SPECT Refurbished FDA UDI
- Generic Name
- SPECT system, annular detector array FDA UDI
- Device Name
- The D-SPECT® system is a single photon emission computing tomography system (SPECT) intended for detection of radioisotope tracer uptake in the patient’s body and to produce cross-sectional images through computer reconstruction of the data. FDA UDI
- Model / Reference
- 002 FDA UDI
- Description
- The D-SPECT® system is a single photon emission computing tomography system (SPECT) intended for detection of radioisotope tracer uptake in the patient’s body and to produce cross-sectional images through computer reconstruction of the data. FDA UDI
Identifiers
- Catalog Number
- 8010517-01 FDA UDI
- Primary DI / UDI-DI
- 07290108670097 FDA UDI
- 510(k) Number
- K161740 FDA UDI
- FDA Product Code
- KPS FDA UDI
- GMDN Term
- SPECT system, annular detector array 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: SPECT system, annular detector array
D-SPECT Refurbished by Spectrum Dynamics Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Spectrum Dynamics Medical Inc.
Sources (1)
- FDA UDI 352a24fd-e7d9-40e8-b06b-6382b6305c07 36 fields · synced May 30, 2026