Identity
- Trade Name
- WHALE FDA UDI
- Generic Name
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
- Model / Reference
- DigiArc 100AU FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970528550018 FDA UDI
- 510(k) Number
- K151280 FDA UDI
- FDA Product Code
- OXO FDA UDIJAA FDA UDI
- GMDN Term
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 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
Dimensions & Sizes
- Size
- Weight — 600 Kilogram FDA UDIWidth — 922 Millimeter FDA UDILength — 2234 Millimeter FDA UDIHeight — 2540 Millimeter FDA UDI
Category: Mobile general-purpose fluoroscopic x-ray system, digital
Whale by Beijing East Whale Imaging Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mobile general-purpose fluoroscopic x-ray system, digital.
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- Zenition — Philips Medical Systems Nederland B.V. · Class II
Cleared under the same submission
K151280 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
- Beijing East Whale Imaging Technology Co., Ltd.
Sources (1)
- FDA UDI 2e97bae1-c486-4bcd-9120-a680a1eac98c 35 fields · synced Jun 1, 2026