Identity
- Trade Name
- 3T 32Ch Torso Coil - Anterior FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- The NeoCoil 3.OT 32-Channel Torso Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the chest, abdomen, and pelvic area in Magnetic Resonance Imaging Systems. The coil consists of 2 antenna arrays; a posterior and an anterior. The posterior array contains 17 elements to achieve 16 channels and is enclosed in a rigid housing. The anterior array also contains 17 elements to achieve the later 16 channels but is enclosed in a flexible housing. The coil is wrapped around the patient's torso with hook and loop straps. The NeoCoil 3.0T 32-Channel Torso Array Coil is for use with the GE S.OT HD Series MR System (K052293) FDA UDI
- Model / Reference
- 02 FDA UDI
- Description
- The NeoCoil 3.OT 32-Channel Torso Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the chest, abdomen, and pelvic area in Magnetic Resonance Imaging Systems. The coil consists of 2 antenna arrays; a posterior and an anterior. The posterior array contains 17 elements to achieve 16 channels and is enclosed in a rigid housing. The anterior array also contains 17 elements to achieve the later 16 channels but is enclosed in a flexible housing. The coil is wrapped around the patient's torso with hook and loop straps. The NeoCoil 3.0T 32-Channel Torso Array Coil is for use with the GE S.OT HD Series MR System (K052293) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856181003022 FDA UDI
- 510(k) Number
- K073236 FDA UDI
- FDA Product Code
- MOS FDA UDI
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 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: MRI system coil, radio-frequency
3T 32Ch Torso Coil - Anterior by Neocoil, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K073236 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 II | Pending data |
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Manufacturer
- Manufacturer
- Neocoil, Llc
Sources (1)
- FDA UDI 02709963-f37f-4ec8-b857-347cc6caa44c 34 fields · synced May 30, 2026