Inspace 4D Software Package with Extended Functionality

by Siemens Medical Solutions 510(k)

Active United States

510(k) K071513

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK071513	Date26 Jun 2007Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K071513
FDA Product Code: JAK

Device Class: Class II
Regulation: 21 CFR Part 892.1750
Advisory Committee: Radiology
FDA Decision: SESE Substantially Equivalent

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