510(k) K122174
- Device
- PEDIATRIC POSITIONER PAD SET
- Applicant
- GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
- 510(k) number
- K122174
- Product code
- KXH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-11-16
- Date received
- 2012-07-23
- Regulation
- 892.1830
- Classification name
- Cradle, Patient, Radiologic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHELLE HUETTNER
- Address
- 1515 Danner Dr. Aurora OH US 44202 44202
FDA Registration Numbers#
- 3031218453
- 3012901801
- 1835830
- 3012205931
- 3009888740
- 3017397209
- 1450835
- 3027686079
- 8022065
- 1818910
- 3004649480
- 3014310698
- 3027338963
- 3004063527
- 1529041
- 1219183
- 9613299
Source Documents#
Other 510(k) Records For Product Code KXH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K953246 | OCTOROLL | Octostop, Inc. | 1995-09-29 |
| K930124 | VARIANT OF OCTOSTOP AND OCTOPAQUE | Octostop, Inc. | 1994-02-09 |
| K933134 | SPECTRUM DG-P7000 PEDIATRIC CRADLE | Spectrum X-Ray Corp. | 1993-10-07 |
| K930357 | ACCESSORY TO UNIVERSAL OCTOPAQUE | Octostop, Inc. | 1993-07-13 |
| K884292 | STRETCHER TABLE | Fischer Imaging Corp. | 1989-03-31 |
| K863890 | MAMM-AIRE | Ar Custom Medical Products, Ltd. | 1986-10-14 |
| K840463 | DIGITAL CRADLE | Spectrum X-Ray Corp. | 1984-02-21 |
| K813561 | SPECTRUM PEDIATRIC CARDLE TABLE | Spectrum X-Ray Corp. | 1982-01-29 |
Legacy Summary#
summary
FDA Review#
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