Allura Xper FD series and Allura Xper OR Table series

FDA 510(k) clearance K162859 · decided 2016-12-02

Clearance details

K-number

K162859

Device name

Allura Xper FD series and Allura Xper OR Table series

Applicant

Philips Medical Systems Nederland B.V.

Decision

Substantially Equivalent

Date received

2016-10-12

Decision date

2016-12-02

Days to decision

51 days

Clearance type

Traditional

Product code

OWB

Device class

2

Regulation number

892.1650

Medical specialty

Radiology

Advisory committee

Radiology

Location

Best Noord-Brabant, NL

Third-party review

No

Expedited review

No

+ Add to Predicate Builder ◉ Watch Philips Medical Systems Nederland B.V.

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

Recalls involving this device