Identity
- Trade Name
- 5 x 3 x 1 pad FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NecCoil 1 .5T GEM Flex Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. FDA UDI
- Model / Reference
- 48 FDA UDI
- Description
- The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NecCoil 1 .5T GEM Flex Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856181003480 FDA UDI
- 510(k) Number
- K113474 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: MRI system coil, radio-frequency
5 x 3 x 1 pad by Neocoil, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K113474 also covers:
- 1.5T GEM Flex Interface, 8ch Combined, HD-Connector — NEOCOIL, LLC
- 11 x 6.5 x 1.5 pad — NEOCOIL, LLC
- 11 x 6.5 x 1.5 wedge pad — NEOCOIL, LLC
- 11 x 6.5 x 3 pad — NEOCOIL, LLC
- 14 x 4 x 2 wedge pad — NEOCOIL, LLC
- 7.5 x 3.5 x 2 pad — NEOCOIL, LLC
- 8 x 3 x 0.5 pad — NEOCOIL, LLC
- Cable Take-up pad — NEOCOIL, LLC
- Flex Coils Pediatric Stabilizer — NEOCOIL, LLC
- GEM Flex Knee Stabilizer for Curved Tables — NEOCOIL, LLC
- GEM Flex Knee Stabilizer for Flat Tables — NEOCOIL, LLC
- General Purpose Support pad — NEOCOIL, LLC
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 40c2264f-dbbd-42f5-99c2-ce47380eccc3 34 fields · synced May 30, 2026