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Imactis®

FDA UDI

Class II (US FDA UDI)

by Imactis

Identity

Trade Name
IMACTIS® FDA UDI
Generic Name
Electromagnetic surgical navigation device tracking system FDA UDI
Device Name
Transport suitcase for the navigation station of the IMACTIS® CT-NAVIGATION system FDA UDI
Model / Reference
J00197 FDA UDI
Description
Transport suitcase for the navigation station of the IMACTIS® CT-NAVIGATION system FDA UDI

Identifiers

Primary DI / UDI-DI
B681J001971 FDA UDI
510(k) Number
K162314 FDA UDI
FDA Product Code
JAK FDA UDI
GMDN Term
Electromagnetic surgical navigation device tracking system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1750 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

No

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

Category: Electromagnetic surgical navigation device tracking system

Imactis® by Imactis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromagnetic surgical navigation device tracking system.

Cleared under the same submission

K162314 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Imactis

Sources (1)

  • FDA UDI d9bdccf2-b4db-4db3-9fe9-48f3d5688bed 35 fields · synced May 30, 2026