Philips Healthcare (Cleveland) FDA Record
- No warning letters matched by name
Philips Healthcare (Cleveland) has 0 FDA recalls, 0 inspections, 6 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Philips Healthcare (Cleveland)" is on file.
- Latest 510(k)
- Nov 21, 2014
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 6 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K133674 | PHILIPS IQON SPECTRAL CT | Nov 21, 2014 |
| K131773 | BRILLIANCE ICT | Sep 24, 2013 |
| K123599 | INGENUITY DIGITAL PET/CT | Jul 12, 2013 |
| K123576 | IMR SOFTWARE APPLICATION | Jun 7, 2013 |
| K113483 | ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION | Sep 26, 2012 |
| K103483 | INGENUITY TF PET/MR | Nov 23, 2011 |
Philips Healthcare (Cleveland) and the FDA: common questions
Has Philips Healthcare (Cleveland) received an FDA warning letter?
No FDA warning letter addressed to the name "Philips Healthcare (Cleveland)" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Philips Healthcare (Cleveland) received an FDA Form 483?
FDA has not published a Form 483 for "Philips Healthcare (Cleveland)" in its reading room. FDA publishes some Form 483s, not all of them.
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