Identity
- Trade Name
- DRGEM FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, analogue FDA UDI
- Device Name
- 480V3~ / 150kV FDA UDI
- Model / Reference
- SGXR-40S FDA UDI
- Description
- 480V3~ / 150kV FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800011120979 FDA UDI
- 510(k) Number
- K192364 FDA UDI
- FDA Product Code
- KPR FDA UDI
- GMDN Term
- Stationary basic diagnostic x-ray system, analogue FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 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: Stationary basic diagnostic x-ray system, analogue
Drgem by DRGEM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary basic diagnostic x-ray system, analogue.
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- SEDECAL — Sedecal., Sa. · Class II
- Q-RAD System — CARESTREAM HEALTH, INC. · Class II
- X-CEL X-RAY CORPORATION — ARQUILLA, INC. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- X-CEL X-RAY CORPORATION — ARQUILLA, INC. · Class II
Cleared under the same submission
K192364 also covers:
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM 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
- DRGEM Corporation
Sources (1)
- FDA UDI 4ed29453-a197-482b-806b-7d09516ab6db 34 fields · synced May 31, 2026