510(k) K940539
- Device
- STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM
- Applicant
- STANDARD IMAGING, INC.
- 510(k) number
- K940539
- Product code
- KPY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-16
- Date received
- 1994-02-07
- Regulation
- 892.6500
- Classification name
- Shield, Protective, Personnel
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAYMOND T RIDDLE
- Address
- 6213 Middleton Springs Dr., Suite 205, P.O. Box 352 Middleton WI US 53562 53562
FDA Registration Numbers#
- 3016989300
- 3014314985
- 3020824984
- 3033484057
- 3016159368
- 3043648115
- 2087075
- 3016257387
- 2025851
- 3038282968
- 3011526299
- 3043535425
- 3005022483
- 9615270
- 3013285519
- 1225691
- 3000174892
- 3008427684
- 3016758972
- 9616441
- 3013260641
- 3012690638
- 3018781093
- 3005599545
- 3038134332
- 3011344631
- 3014644369
- 3023863246
- 3009222501
- 3032027177
- 3014273526
- 1222742
- 3007165189
- 1053541
- 3002821232
- 3012841710
- 2183301
- 3015495690
- 3003000761
- 3005607112
- 3003808764
- 1825146
- 3012395063
- 3043126854
- 8043817
- 3016739098
- 2024351
- 3007594755
- 3013646819
- 3002806603
- 3013394380
- 3040389667
- 3009688745
- 2134265
- 3014342658
- 3005785003
- 3016763307
- 3026630
- 3011137372
- 3011593607
- 3016872092
- 3008005217
- 1061124
- 3031590635
- 3013401749
- 3015416207
- 3009420946
- 1836161
- 3017896194
- 3010353405
- 3008044484
- 3013374101
- 3013070673
- 3014819517
- 3017180923
- 3026326493
- 1450835
- 2182762
- 2518443
- 3010280860
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KPY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110900 | DISPOSABLE THYROID COLLAR | Bloxr Corporation | 2011-06-24 |
| K962622 | INTRA-ORAL THERMOPLASTIC SHIELD | Medtec, Inc. | 1996-10-01 |
| K954456 | THERMOPLASTIC SHIELD | Medtec, Inc. | 1995-12-21 |
| K954146 | UTK-DTE AUTILARY SHIELD | Mallinckrodt Medical | 1995-12-06 |
| K953610 | AUKULYTE | Aukland Medical Plastics, Inc. | 1995-09-26 |
| K951004 | 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) | Kenex , Ltd. | 1995-04-10 |
| K951003 | KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) | Kenex , Ltd. | 1995-04-03 |
| K934206 | MAVIG ANGIO SHIELD MODELS 6290 & 6272 | F. Walter Hanel GmbH | 1993-10-07 |
| K912326 | DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS | Davis Lead Aprons, Inc. | 1992-03-18 |
| K912327 | DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. | Davis Lead Aprons, Inc. | 1992-03-18 |
| K912378 | DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS | Davis Lead Aprons, Inc. | 1992-03-18 |
| K900970 | RADIATION PROTECTION GLASSES | Infab Corp. | 1990-05-01 |
| K896511 | DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL | E.I. Dupont DE Nemours & Co., Inc. | 1989-12-22 |
| K896289 | RADIATION PROTECTION APRON | Infab Corp. | 1989-12-14 |
| K871502 | PERSONNEL PROTECTIVE SHIELD | Cis-Us, Inc. | 1987-05-08 |
Legacy Summary#
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FDA Review#
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