Model H170 Pediatric Chest X-Ray Unit

FDA 510(k) K915667 · H.L. Lyons Co.

Substantially Equivalent

510(k) numberK915667

Submission

Device name
Model H170 Pediatric Chest X-Ray Unit
Applicant
H.L. Lyons Co.
Louisville, KY, US
Received
December 18, 1991
Decision date
January 31, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IXY – Holder, Radiographic Cassette, Wall-Mounted
Device class
Class I (low risk)
Regulation
21 CFR 892.1880
Specialty
Radiology

Other 510(k)s with product code IXY

510(k)DeviceApplicantDecision
K953402Universix 190IXY · Traditional Philips Medical Systems (Cleveland), Inc.08/11/1995SE
K953336VRS 3 Wall StandIXY · Traditional Philips Medical Systems (Cleveland), Inc.08/11/1995SE
K946114Sensori-Motor Rating ScaleIXY · Traditional Cmed04/28/1995SE
K946260NTBS-1417, 1436, TBS-1417IXY · Traditional Scott Imaging Intl., Inc.03/31/1995SE
K930249Bc/Wt/PfIXY · Traditional Tingle X-Ray Products, Inc.04/27/1993SE
K930230Radiographic Wall-Mounted Cassette HolderIXY · Traditional American Medical Sales, Inc.04/27/1993SE
K925934Wall Bucky Holders Lt. & Rt. Hand, & Center MountIXY · Traditional Continental X-Ray Corp.03/04/1993SE
K924445BA-4 Wall Bucky and BA-42 Tilting Wall BuckyIXY · Traditional Control-X, Inc.02/19/1993SE
K922443Vert-X Universal Vertical Bucky StandIXY · Traditional Afp Imaging Corp.10/26/1992SE
K895034Buckys Models YMB-15A, YMB-15B and YMB-15CIXY · Traditional Yamato Medical Corp.11/15/1989SE

Questions and answers

When was Model H170 Pediatric Chest X-Ray Unit cleared by the FDA?

Model H170 Pediatric Chest X-Ray Unit (K915667) received a 510(k) decision of Substantially Equivalent on January 31, 1992, 44 days after the submission was received.

What is the product code of K915667?

The FDA product code is IXY – Holder, Radiographic Cassette, Wall-Mounted, a Class I (low risk) device regulated under 21 CFR 892.1880.