Identity
- Trade Name
- PEDIATRIC SCANNING PLATFORM FOR OMNITOM FDA UDI
- Generic Name
- Basic diagnostic x-ray system table, non-powered FDA UDI
- Model / Reference
- 0-00171-001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10815411020434 FDA UDI
- 510(k) Number
- K171183 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Basic diagnostic x-ray system table, non-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic diagnostic x-ray system table, non-powered
Pediatric Scanning Platform For Omnitom by Neurologica Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic diagnostic x-ray system table, non-powered.
- SPT2 Radiographic Table — CARESTREAM HEALTH, INC. · Class II
- PROGNOST XP — PROTEC GmbH & Co. KG · Class II
- SEDECAL — Sedecal., Sa. · Class II
- PATIENT TABLE — Pausch, L.L.C. · Class II
- CARESTREAM SPT1 Radiographic Table — CARESTREAM HEALTH, INC. · Class II
- CARESTREAM DR Long Length Imaging Stand — CARESTREAM HEALTH, INC. · Class II
- QT-730 — CARESTREAM HEALTH, INC. · Class II
- Z-TABLE — CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő Részvénytársaság · Class II
Cleared under the same submission
K171183 also covers:
- ADAPTER, HILL-ROM CARE ASSIST ES BED — Neurologica Corporation
- CT SCANNER, NL5000 — Neurologica Corporation
- NEONATAL SCANNING PLATFORM, NL5000 — Neurologica Corporation
- OPTION ASSY, OMNITOM UNIVERSAL TRANSFER BOARD — Neurologica Corporation
- OPTION HILL ROM ADVANTA BED ADAPTER — Neurologica Corporation
- OPTION, EXTENDED HILL-ROM PROGRESSA PULMONARY SCAN BOARD — Neurologica Corporation
- OPTION, HILL-ROM CHG BED ADAPTER — Neurologica Corporation
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
- Neurologica Corporation
Sources (1)
- FDA UDI b5b1b8e0-3aa8-4762-beeb-a0cdaaee9de2 33 fields · synced May 30, 2026