Variant of Octostop and Octopaque

Q: What is the product code of K930124?

The FDA product code is KXH – Cradle, Patient, Radiologic, a Class I (low risk) device regulated under 21 CFR 892.1830.

FDA 510(k) K930124 · Octostop, Inc.

Substantially Equivalent

510(k) numberK930124

Submission

Device name: Variant of Octostop and Octopaque
Applicant: Octostop, Inc.
Montreal, Qc., CA
Received: January 12, 1993
Decision date: February 9, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: KXH – Cradle, Patient, Radiologic
Device class: Class I (low risk)
Regulation: 21 CFR 892.1830
Specialty: Radiology

Other 510(k)s with product code KXH

510(k)	Device	Applicant	Decision
K122174	Pediatric Positioner Pad SetKXH · Traditional	Ge Healthcare Coils (Usa Instruments, Inc.)	11/16/2012SE
K953246	OctorollKXH · Traditional	Octostop, Inc.	09/29/1995SE
K933134	Spectrum DG-P7000 Pediatric CradleKXH · Traditional	Spectrum X-Ray Corp.	10/07/1993SE
K930357	Accessory to Universal OctopaqueKXH · Traditional	Octostop, Inc.	07/13/1993SE
K884292	Stretcher TableKXH · Traditional	Fischer Imaging Corp.	03/31/1989SE
K863890	Mamm-AireKXH · Traditional	Ar Custom Medical Products, Ltd.	10/14/1986SE
K840463	Digital CradleKXH · Traditional	Spectrum X-Ray Corp.	02/21/1984SE
K813561	Spectrum Pediatric Cardle TableKXH · Traditional	Spectrum X-Ray Corp.	01/29/1982SE

More from Spectrum X-Ray Corp.

510(k)	Device	Decision
K972766	Pivoting Compensating Filters for the HeadKPR · Traditional	08/14/1997SE
K963941	The Pharaoh Compensating FilterKPR · Traditional	11/27/1996SE
K953246	OctorollKXH · Traditional	09/29/1995SE
K952871	Ridges PlusKPR · Traditional	07/20/1995SE
K942916	Octopaque UniversalIXQ · Traditional	09/08/1994SE
K940306	Octostop Compensating FiltersKPR · Traditional	09/06/1994SE
K935444	Octostop(R) Chair (New ModelIXR · Traditional	09/02/1994SE
K930357	Accessory to Universal OctopaqueKXH · Traditional	07/13/1993SE
K926069	Wrist TractionKPR · Traditional	01/21/1993SE
K913711	Gentle SlopeKPR · Traditional	10/14/1992SE

Questions and answers

When was Variant of Octostop and Octopaque cleared by the FDA?

Variant of Octostop and Octopaque (K930124) received a 510(k) decision of Substantially Equivalent on February 9, 1994, 393 days after the submission was received.

What is the product code of K930124?

The FDA product code is KXH – Cradle, Patient, Radiologic, a Class I (low risk) device regulated under 21 CFR 892.1830.