Identity
- Trade Name
- Model 7600 FDA UDI
- Generic Name
- Nuclear medicine system synchronizer FDA UDI
- Device Name
- Cardiac Gating Module FDA UDI
- Model / Reference
- 3299-19-15 FDA UDI
- Description
- Cardiac Gating Module FDA UDI
Identifiers
- Catalog Number
- 3299-19-15 FDA UDI
- Primary DI / UDI-DI
- 00816396021105 FDA UDI
- 510(k) Number
- K110987 FDA UDI
- FDA Product Code
- DRT FDA UDI
- GMDN Term
- Nuclear medicine system synchronizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 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
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Weight — 3.9 Pound FDA UDIDepth — 5.18 Inch FDA UDIWidth — 7.94 Inch FDA UDIHeight — 7.49 Inch FDA UDI
Category: Nuclear medicine system synchronizer
Model 7600 by Ivy Biomedical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nuclear medicine system synchronizer.
- Model 7600 — Ivy Biomedical Systems, Inc. · Class II
- Model 7600 — Ivy Biomedical Systems, Inc. · Class II
- Model 7600 — Ivy Biomedical Systems, Inc. · Class II
- Model 7600EP — Ivy Biomedical Systems, Inc. · Class II
- Model 7600 — Ivy Biomedical Systems, Inc. · Class II
- Model 7600 — Ivy Biomedical Systems, Inc. · Class II
- UPMM Serial — Ivy Biomedical Systems, Inc. · Class II
- Model 7800EP — Ivy Biomedical Systems, Inc. · Class II
Cleared under the same submission
K110987 also covers:
- Model 7600 — Ivy Biomedical Systems, Inc.
- Model 7600 — Ivy Biomedical Systems, Inc.
- Model 7600 — Ivy Biomedical Systems, Inc.
- Model 7600 — Ivy Biomedical Systems, Inc.
- Model 7600 — Ivy Biomedical Systems, Inc.
- Model 7600 — Ivy Biomedical Systems, Inc.
- Model 7600 — Ivy Biomedical Systems, Inc.
- Model 7600 — Ivy Biomedical Systems, Inc.
- Model 7600 — Ivy Biomedical Systems, Inc.
- Model 7600 — Ivy Biomedical Systems, Inc.
- Model 7600 — Ivy Biomedical Systems, Inc.
- Model 7600 — Ivy Biomedical Systems, Inc.
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
- Ivy Biomedical Systems, Inc.
Sources (1)
- FDA UDI e26086b1-7535-49dd-a4a5-f1a398931cbe 37 fields · synced Jun 9, 2026