Orthoralix Sd/Orthoralix Sd Ceph

by Philips Medical Systems North America, Inc. 510(k)

Active United States

510(k) K890351

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK890351	Date15 Jun 1989Cleared	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Withdrawn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: K890351
FDA Product Code: IZF

Device Class: Class II
Regulation: 21 CFR Part 892.1740
Advisory Committee: Radiology
FDA Decision: SESE Substantially Equivalent

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