Identity
- Trade Name
- D630 to D670 DR Upgrade FDA UDI
- Generic Name
- Stationary gamma camera system FDA UDI
- Device Name
- D630 to D670 DR NM GANTRY UPGRADE KIT FDA UDI
- Model / Reference
- H2401DS FDA UDI
- Description
- D630 to D670 DR NM GANTRY UPGRADE KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682154338 FDA UDI
- 510(k) Number
- K093514 FDA UDI
- FDA Product Code
- KPS FDA UDIJAK FDA UDI
- GMDN Term
- Stationary gamma camera system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1200 FDA UDI892.1750 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Full-body CT systemStationary gamma camera system
D630 to D670 DR Upgrade by GE Hualun Medical Systems Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary gamma camera system.
- 850ES to 850 Upgrade — Ge Medical Systems Israel , Ltd. · Class II
- 870ES to 870 DR Upgrade — Ge Medical Systems Israel , Ltd. · Class II
- Discovery — Ge Medical Systems Israel , Ltd. · Class II
- NMCT — Ge Medical Systems Israel , Ltd. · Class II
- Discovery — Ge Medical Systems Israel , Ltd. · Class II
- 870DR to 870 CZT Upgrade — Ge Medical Systems Israel , Ltd. · Class II
- NMCT — Ge Medical Systems Israel , Ltd. · Class II
- BodyMD — Ddd-Diagnostic A/S · Class II
Cleared under the same submission
K093514 also covers:
- 830 to 870 DR Upgrade — Ge Medical Systems Israel , Ltd.
- 830 to 870 DR Upgrade — Ge Medical Systems Israel , Ltd.
- 870ES to 870 DR Upgrade — Ge Medical Systems Israel , Ltd.
- D630 to D670 DR Upgrade — Ge Medical Systems Israel , Ltd.
- D670 Pro Upgrade — Ge Medical Systems Israel , Ltd.
- D670 Upgrade — Ge Medical Systems Israel , Ltd.
- Discovery — Ge Medical Systems Israel , Ltd.
- Discovery — Ge Medical Systems Israel , Ltd.
- Discovery — Ge Medical Systems Israel , Ltd.
- Discovery — Ge Medical Systems Israel , Ltd.
- Discovery — Ge Medical Systems Israel , Ltd.
- Discovery 670 ES — Ge Medical Systems Israel , Ltd.
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
- GE Hualun Medical Systems Co., Ltd
Sources (1)
- FDA UDI 96aa540f-d83c-486f-ad58-17559cd3d639 34 fields · synced Jun 1, 2026