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Precision

FDA UDI

Class II (US FDA UDI)

by Ge Medical Systems, Inc.

Identity

Trade Name
Precision FDA UDI
Generic Name
Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Device Name
P600 FP X-ray High-Voltage Generator Cabinet FDA UDI
Model / Reference
600FP FDA UDI
Description
P600 FP X-ray High-Voltage Generator Cabinet FDA UDI

Identifiers

Primary DI / UDI-DI
00840682120982 FDA UDI
510(k) Number
K133553 FDA UDI
FDA Product Code
JAA FDA UDI
GMDN Term
Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 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

Category: Stationary general-purpose fluoroscopic x-ray system, digital

Precision by Ge Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary general-purpose fluoroscopic x-ray system, digital.

Cleared under the same submission

K133553 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ge Medical Systems, Inc.

Sources (1)

  • FDA UDI 57960062-13b3-42fb-a45c-c9e3d34bbedb 34 fields · synced Jun 1, 2026