(144 days)
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No
The summary describes a standard dental X-ray system and does not mention any AI or ML capabilities, image processing beyond basic X-ray capture, or performance studies related to algorithmic analysis.
No
The device is described as an X-ray system for examination and diagnosis, not for treating diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states "diagnosis of diseases of the teeth."
No
The device is described as an "extra oral source X-ray system," which inherently includes hardware components (the X-ray source and system). The summary does not mention any software-only aspects.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is an extra oral source X-ray system. It uses X-rays to create images of the teeth externally to the body. It does not analyze specimens taken from the body.
- Intended Use: The intended use is for "dental radiographic examination and diagnosis of diseases of the teeth," which is achieved through imaging, not through the analysis of biological samples.
Therefore, based on the provided information, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
Product codes
EHD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
teeth
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
Appendix 1 - 510 (k) SUMMARY
510(k) summary for STRATO X
Identification
| Applicant | Villa Sistemi Medicali S.p.A.
Via delle Azalee 3,
20090 BUCCINASCO - Milan- Italy
Registration Number: 8021091 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | dr. Roberto Daglio – QA Director |
| Telephone (applicant) | + 39 02 48859233 |
| Designated Agent
in the US | Andrew Hryndza
Del Medical
11550 West King Street
Franklin Park
Illinois 60131
Tel. 847-288-7000 FAX. 847-288-7911 |
| Manufacturing site | Villa Sistemi Medicali S.p.A.
Via delle Azalee 3,
20090 BUCCINASCO - Milan - Italy |
Trade name: ENDOS DC
Common name: ENDOS DC
Classification name: according to 21 CFR 872-1800, ENDOS DC is in Class II.
Substantial equivalent device: the ENDOS DC is defined as Substantially Equivalent (SE) to the GENDEX DENTSPLY model 765DC. The predicate device has been approved by FDA and has 510(k) approval number K992610
1
| ENDOS DC | GENDEX 765 DC | |
|---|---|---|
| Intended use | extra oral source X-ray | |
| system for dental | ||
| radiographic examination | ||
| of the teeth | extra oral source X-ray | |
| system for dental | ||
| radiographic examination | ||
| High Voltage value | 65 kVp+/-5% | 65 kVp +/- 3kV |
| Tube current | 4-5 mA +/-5% | 7 mA +/- 5% |
| Focal spot size | 0.7 mm (IEC 336) | 0.4 mm (IEC 336) |
| Anode inclination | 19° | 12.5° |
| Total filtration | > 2.0 mm Al | 2.0 mm Al |
| HVL | > 1.5 mm Al | 2.0 mm Al |
| H.V. generator: | High frequency | High frequency |
| X-Ray exposure | ||
| time control | Automatic - pre- | |
| programmed | ||
| Microprocessor | ||
| Controlled | Automatic - pre- | |
| programmed | ||
| Microprocessor | ||
| Controlled | ||
| X-Ray exposure | ||
| timing | 0.010 sec to 2 sec | 0.020 sec to 2 sec |
| Electrical | ||
| characteristics | 120 V | |
| 4.5 impulsive A max | 120 V | |
| 5 impulsive A max | ||
| Focus film distance | > 20 cm | |
| or > 30cm | > 20 cm | |
| or > 30cm | ||
| Leakage radiation |