CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD
FDA 510(k) clearance K861019 · decided 1986-04-02
Clearance details
- K-number
- K861019
- Device name
- CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD
- Applicant
- Phase One Disign Co.
- Decision
- Substantially Equivalent
- Date received
- 1986-03-18
- Decision date
- 1986-04-02
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- EAK
- Device class
- 1
- Regulation number
- 892.6500
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- San Rafael, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 (K952233) | Victoreen, Inc. | 1995-06-16 |
| ED CORP RADIATION SCREEN (K944445) | Med Corp. | 1995-05-11 |
| MULTIPLE ED1600 SERIES RADIATION SHIELDS (K944772) | Image Diagnostics, Inc. | 1994-10-20 |
| MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS (K896949) | Innovative Products Mfg. | 1990-02-16 |
| MODULAR X-RAY BARRIERS (K850814) | Victoreen, Inc. | 1985-04-10 |
| LEAD PLASTIC VIEWING PANELS (K850816) | Victoreen, Inc. | 1985-04-10 |
Recalls involving this device
No recalls on record reference this clearance.