ORTHOPHOS AND ORTHOPHOS C
FDA 510(k) clearance K895467 · decided 1989-11-17
Clearance details
- K-number
- K895467
- Device name
- ORTHOPHOS AND ORTHOPHOS C
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-09-11
- Decision date
- 1989-11-17
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- EHD
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Iselin, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Siemens Medical Solutions USA
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Portable Dental X-ray System Model PDX nova (K260367) | PDX Co., Ltd. | 2026-05-27 |
| NOMAD Pro 3 (K253864) | Dental Imaging Technologies Corporation | 2026-03-20 |
| Dental X-RAY Unit (AJX200) (K252110) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2026-03-12 |
| Portable Dental X-ray Device (GT-1) (K254018) | Guilin Refine Medical Instrument Co., Ltd. | 2026-02-19 |
| Diagnostic X-Ray Equipment Model POCT22 (K252909) | Ningbo Runyes Medical Instrument Co., Ltd. | 2026-02-03 |
| Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (K251438) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2025-09-04 |
| Rextar Pro (K242185) | Raypia Co., Ltd. | 2024-12-04 |
| XERO-alpha (K242591) | DRTECH Corporation | 2024-11-01 |
| WERAY (K241963) | Picopack Co., Ltd. | 2024-07-30 |
| LifeRay Intraoral Handheld X-ray System (K241305) | Lucas Lifecare | 2024-07-05 |
| REMEX-GR100 (K240759) | Remedi Co., Ltd. | 2024-05-13 |
| XVbeam2000 (K233914) | Shenzhen Xpectvision Technology Co., Ltd. | 2024-02-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008) | Siemens Medical Solutions USA, Inc. | 2024-09-23 |
| MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007) | Siemens Medical Solutions USA, Inc. | 2020-08-21 |
| MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006) | Siemens Medical Solutions USA, Inc. | 2019-12-10 |
| Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005) | Siemens Medical Solutions USA, Inc. | 2017-09-29 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003) | Siemens Medical Solutions USA, Inc. | 2017-03-23 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001) | Siemens Medical Solutions USA, Inc. | 2016-05-12 |
| MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002) | Siemens Medical Solutions USA, Inc. | 2016-01-13 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011) | Siemens Medical Solutions USA, Inc. | 2015-04-21 |