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Model 7800

FDA UDI

Class II (US FDA UDI)

by Ivy Biomedical Systems, Inc.

Identity

Trade Name
Model 7800 FDA UDI
Generic Name
X-ray system synchronizer FDA UDI
Device Name
Cardiac Gating Module FDA UDI
Model / Reference
3300-00-15 FDA UDI
Description
Cardiac Gating Module FDA UDI

Identifiers

Catalog Number
3300-00-15 FDA UDI
Primary DI / UDI-DI
00816396021228 FDA UDI
510(k) Number
K110987 FDA UDI
FDA Product Code
DRT FDA UDI
GMDN Term
X-ray 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
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Weight — 5.6 Pound FDA UDI
Depth — 6.10 Inch FDA UDI
Width — 9.25 Inch FDA UDI
Height — 8.72 Inch FDA UDI

Category: X-ray system synchronizer

Model 7800 by Ivy Biomedical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as X-ray system synchronizer.

Cleared under the same submission

K110987 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ivy Biomedical Systems, Inc.

Sources (1)

  • FDA UDI 09709792-2e34-4a23-93f6-be5871cae11f 37 fields · synced Jun 9, 2026