Pediatric Positioner Pad Set
FDA 510(k) K122174 · Ge Healthcare Coils (Usa Instruments, Inc.)
510(k) numberK122174
Submission
- Device name
- Pediatric Positioner Pad Set
- Applicant
- Ge Healthcare Coils (Usa Instruments, Inc.)
Aurora, OH, US - Received
- July 23, 2012
- Decision date
- November 16, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K953246 | OctorollKXH · Traditional | Octostop, Inc. | 09/29/1995SE |
| K930124 | Variant of Octostop and OctopaqueKXH · Traditional | Octostop, Inc. | 02/09/1994SE |
| 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 |
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Questions and answers
When was Pediatric Positioner Pad Set cleared by the FDA?
Pediatric Positioner Pad Set (K122174) received a 510(k) decision of Substantially Equivalent on November 16, 2012, 116 days after the submission was received.
What is the product code of K122174?
The FDA product code is KXH – Cradle, Patient, Radiologic, a Class I (low risk) device regulated under 21 CFR 892.1830.