Identity
- Trade Name
- iQ Flex FDA UDI
- Generic Name
- Diagnostic x-ray system generator, portable FDA UDI
- Device Name
- This Mobile X-ray System (Model: iQFlex M/iQFlex MD) consists of a LED display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, and a collimator. A cart or a stand can be used with the iQFlex MD. The iQFlex M/iQFlex MD is used with a film-cassette or flat-panel detector. FDA UDI
- Model / Reference
- MD FDA UDI
- Description
- This Mobile X-ray System (Model: iQFlex M/iQFlex MD) consists of a LED display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, and a collimator. A cart or a stand can be used with the iQFlex MD. The iQFlex M/iQFlex MD is used with a film-cassette or flat-panel detector. FDA UDI
Identifiers
- Catalog Number
- 500MC0800 FDA UDI
- Primary DI / UDI-DI
- G221500MC0800 FDA UDI
- 510(k) Number
- K221081 FDA UDI
- FDA Product Code
- IZL FDA UDI
- GMDN Term
- Diagnostic x-ray system generator, portable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1720 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
Yes
FDA UDI
Category: Diagnostic x-ray system generator, portable
iQ Flex by First Source Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- POSKOM Co., Ltd. — Poskom Co., Ltd. · Class II
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Cleared under the same submission
K221081 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
- First Source Inc.
Sources (1)
- FDA UDI 7f10c4c4-6c72-4949-9482-085ac3721a9d 35 fields · synced May 30, 2026