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Upmm-X

FDA UDI

Class II (US FDA UDI)

by Ivy Biomedical Systems, Inc.

Identity

Trade Name
UPMM-X FDA UDI
Generic Name
Nuclear medicine system synchronizer FDA UDI
Device Name
Cardiac Gating Module FRU FDA UDI
Model / Reference
4161-00-01 FDA UDI
Description
Cardiac Gating Module FRU FDA UDI

Identifiers

Catalog Number
4161-00-01 FDA UDI
Primary DI / UDI-DI
00816396021563 FDA UDI
510(k) Number
K091985 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
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Height — 2.5 Inch FDA UDI
Width — 12 Inch FDA UDI
Depth — 6.7 Inch FDA UDI
Weight — 2.5 Pound FDA UDI

Category: Nuclear medicine system synchronizer

Upmm-X 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.

Cleared under the same submission

K091985 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 131ac663-57bc-48ab-8faa-c87293a39d44 37 fields · synced Jun 9, 2026