Identity
- Trade Name
- Low Energy High Res Collimator FDA UDI
- Generic Name
- Multi-hole nuclear medicine system collimator, low-energy FDA UDI
- Model / Reference
- 04355108 FDA UDI
Identifiers
- Catalog Number
- 4355108.. FDA UDI
- Primary DI / UDI-DI
- 04056869001906 FDA UDI
- 510(k) Number
- K142006 FDA UDI
- FDA Product Code
- KPS FDA UDI
- GMDN Term
- Multi-hole nuclear medicine system collimator, low-energy 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
No
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
No
FDA UDI
Category: Multi-hole nuclear medicine system collimator, low-energy
Low Energy High Res Collimator by Siemens Medical Solutions Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-hole nuclear medicine system collimator, low-energy.
- Diverging Collimator — Digirad Corp. · Class I
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- LEAP Collimator — Digirad Corp. · Class I
- High Energy Collimator — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Medium Energy Collimator Asm Symbia — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Fan Beam Collimator — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
Cleared under the same submission
K142006 also covers:
- Collimator Asm Smart Zoom — SIEMENS MEDICAL SOLUTIONS USA, INC.
- Fan Beam Collimator — SIEMENS MEDICAL SOLUTIONS USA, INC.
- Fan Beam Collimator Asm Symbia — SIEMENS MEDICAL SOLUTIONS USA, INC.
- HI-EN Collimator Asm Symbia — SIEMENS MEDICAL SOLUTIONS USA, INC.
- HI_RES Collimator Asm Symbia — SIEMENS MEDICAL SOLUTIONS USA, INC.
- High Energy Collimator — SIEMENS MEDICAL SOLUTIONS USA, INC.
- LEAP Collimator Asm Symbia — SIEMENS MEDICAL SOLUTIONS USA, INC.
- LPHR COLLIMATOR ASM SYMBIA — SIEMENS MEDICAL SOLUTIONS USA, INC.
- Low Energy Ultra HighRes Collimator — SIEMENS MEDICAL SOLUTIONS USA, INC.
- Low Energy, All Purpose — SIEMENS MEDICAL SOLUTIONS USA, INC.
- Low Pen HR Collimator Symbia E — SIEMENS MEDICAL SOLUTIONS USA, INC.
- Medium Energy Collimator — SIEMENS MEDICAL SOLUTIONS USA, INC.
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
- Siemens Medical Solutions Usa, Inc.
Sources (1)
- FDA UDI f9e872a9-5edf-433f-9fe6-ff863f418cb6 36 fields · synced Jun 8, 2026