FDA Inspection
X-Ray Systems, Inc.X-Ray Systems, Inc. – FDA Inspection, Sep 3, 2026
Record Details
This FDA Inspection record concerns X-Ray Systems, Inc., with an inspection on September 3, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
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ID · e2e842fb-5165-4cbd-b277-dcc3260d19d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1334778
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.3.10Design and development changes not identified
- ISO 13485:2016 Clause 7.3.9Design and development changes not identified
Full citation text and observation details available on the Dashboard.
Other FDA inspections of X-Ray Systems, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 18, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 23, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 21, 2010 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for X-Ray Systems, Inc.
- FDA Inspection 1163948 - 2022-03-04
- FDA Inspection 1102620 - 2019-09-18
- FDA Inspection 1015986 - 2017-06-23
- FDA Inspection 663009 - 2010-05-21
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