Bc/Wt/Pf

FDA 510(k) K930249 · Tingle X-Ray Products, Inc.

Substantially Equivalent

510(k) numberK930249

Submission

Device name
Bc/Wt/Pf
Applicant
Tingle X-Ray Products, Inc.
Vance, AL, US
Received
January 19, 1993
Decision date
April 27, 1993
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
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
K915667Model H170 Pediatric Chest X-Ray UnitIXY · Traditional H.L. Lyons Co.01/31/1992SE
K895034Buckys Models YMB-15A, YMB-15B and YMB-15CIXY · Traditional Yamato Medical Corp.11/15/1989SE

More from Yamato Medical Corp.

510(k)DeviceDecision
K926554525 SFQ X-Ray Control W/High Voltage GeneratorKPR · Traditional 05/17/1993SE
K860203TXR 325 X-Ray Control with High Voltage GeneratorIZO · Traditional 01/30/1986SE

Questions and answers

When was Bc/Wt/Pf cleared by the FDA?

Bc/Wt/Pf (K930249) received a 510(k) decision of Substantially Equivalent on April 27, 1993, 98 days after the submission was received.

What is the product code of K930249?

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