Mammographic X-Ray System
FDA 510(k) K913732 · Lorad Medical Systems, Inc.
510(k) numberK913732
Submission
- Device name
- Mammographic X-Ray System
- Applicant
- Lorad Medical Systems, Inc.
Danbury, CT, US - Received
- August 20, 1991
- Decision date
- February 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Giotto USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K921962 | Lorad Digital Spot MammographyIZH · Traditional | 11/23/1992SE |
| K922619 | Digitizer, Model # 3-000A-1518IZH · Traditional | 07/01/1992SE |
| K913478 | Radiographic Film Marking SystemJAC · Traditional | 10/15/1991SE |
| K894935 | S-70 Portable Dental X-Ray SystemEHD · Traditional | 04/25/1990SE |
| K894643 | RT-125 Rough Terrain Mobile X-Ray UnitIZL · Traditional | 12/14/1989SE |
| K882875 | Stereotactic Breast Lesion Localization AccessoryIZH · Traditional | 11/07/1988SE |
| K842102 | LoradIZH · Traditional | 07/17/1984SE |
Questions and answers
When was Mammographic X-Ray System cleared by the FDA?
Mammographic X-Ray System (K913732) received a 510(k) decision of Substantially Equivalent on February 3, 1992, 167 days after the submission was received.
What is the product code of K913732?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.